Category Archives: Pharmacy

Introduction

Biomedical research is the cornerstone of the pharmaceutical industry. It is the process of discovering new drugs, therapies, and medical devices that improve the health and well-being of individuals. However, conducting Biomedical Investigation requires adherence to strict ethical guidelines to ensure the safety and protection of human subjects. The Biomedical Research Act, which was passed in 2001. Aims to regulate the conduct of Biomedical Investigation in the United States. In this essay, we will examine the impacts of the Biomedical Research Act on the pharmaceutical industry.

 Background of the Biomedical Research Act

The Biomedical Research Act was signed into law in 2001 by President George W. Bush. Its primary purpose was to streamline the regulatory process for Biomedical Investigation and to ensure that it was conducted in an ethical and responsible manner. The Act established the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) to oversee the ethical conduct of biomedical research.

 Impact on Clinical Trials

The Biomedical Research Act has had a significant impact on the conduct of clinical trials. Clinical trials are a critical component of biomedical investigation. As they are to test the safety and efficacy of new drugs and therapies. The Act established the Institutional Review Board (IRB) system. Which is responsible for reviewing and approving all clinical trials involving human subjects. The IRB is required to ensure that the trial is conducted in accordance with ethical guidelines. And that the rights and welfare of the participants are protected.

Biomedical Research and Informed Consent

The Biomedical Research Act also had an impact on informed consent. The process of informed consent involves actively informing potential participants in a clinical trial about the trial’s purpose, procedures, risks, and benefits. Participants are then able to make voluntary decisions regarding their participation. The Act mandates that researchers obtain informed consent from all individuals involved in clinical trials. To meet this requirement, researchers must obtain written consent from participants and ensure that the information is provided in a language that the participant can understand. This active approach to informed consent ensures that individuals have a comprehensive understanding of the trial and can make informed decisions about their participation. Promoting ethical and responsible research practices.

Biomedical Research and Data Privacy

The Biomedical Research Act has also had an impact on data privacy. Biomedical investigation often involves the collection and analysis of personal health information. The Act requires that the privacy of all participants in Biomedical Investigation is in protection. Researchers are in requirement to obtain consent from participants to use their personal health information and to take steps to protect the confidentiality of that information.

Impact on Research Funding

The Biomedical Research Act has also had an impact on investigation funding. The Act established the National Institutes of Health (NIH) to fund Biomedical Investigation in the United States. The NIH is responsible for funding research into a wide range of diseases and conditions, from cancer to diabetes to Alzheimer’s disease. The Act also provides funding for the training of researchers and for the development of new technologies and techniques for Biomedical Investigation.

Impact of Biomedical Research

The Biomedical Research Act has had a significant impact on the development of new drugs. The Act has been helping to streamline the drug approval process. Allowing new drugs to be releasing to market more quickly. This has led to the development of new treatments for a wide range of diseases and conditions, including cancer, heart disease, and HIV/AIDS.

• The Biomedical Research Act has expedited the drug approval process, reducing the time it takes to bring new drugs to market.
• Faster drug approval has led to the development of new treatments for diseases like cancer, heart disease, and HIV/AIDS.
• Streamlining the drug approval process has also reduced costs for pharmaceutical companies. Allowing them to invest in more research and development.
• The Act has encouraged innovation in the pharmaceutical industry, leading to the discovery of new drug targets and therapeutic approaches.
• Ultimately, the impact of the Biomedical Research Act on drug development has improved the health and well-being of individuals suffering from a wide range of diseases and conditions.

Conclusion

In conclusion, the Biomedical Investigation Act has had a significant impact on the pharmaceutical industry. The Act has been helping to ensure that biomedical investigation is conducting in an ethical and responsible manner. And has led to the development of new treatments for a wide range of diseases and conditions. The Act has also helped to streamline the drug approval process. Allowing new drugs to be releasing to market more quickly. Overall, the Biomedical Research Act has had a positive impact on the health and well-being of individuals in the United States and around the world.

Introduction

Over-the-counter (OTC) hospitality is rapidly gaining popularity in the hospitality industry. It provides businesses with an affordable, easy-to-use point of sale (POS) solution. The system is designed to streamline processes, improve customer experiences, and increase revenue. In this essay, we will discuss how Hospitalities is revolutionizing the power of POS solutions.

What is OTC Hospitality?

OTC hospitality is a cloud-based POS system that enables businesses to process transactions, manage inventory, and generate reports. It is designed to simplify operations for restaurants, bars, cafes, and other hospitality businesses. OTC hospitality allows businesses to customize menus, process payments, and track inventory in real-time. It is a cost-effective alternative to traditional POS systems that require significant investments in hardware, software, and maintenance.

How Does OTC Hospitality Work?

OTC hospitality works by connecting a business’s POS system to the cloud. It allows businesses to access data from anywhere, at any time, using a mobile device or computer. The system uses an intuitive interface that makes it easy for staff to process orders and manage inventory. OTC Hospitalities provides businesses with real-time insights into sales, inventory, and customer behavior. The system can also generate reports that provide valuable insights into a business’s performance.

The Benefits of OTC Hospitality

OTC Hospitalities offers numerous benefits to businesses. The system is affordable, easy to use, and requires minimal maintenance. Hospitalities can help businesses to:

• Streamline Operations: Hospitalities simplifies processes and reduces the time it takes to process orders. It allows businesses to process transactions, manage inventory, and generate reports in real-time.
• Improve Customer Experience: OTC Hospitalities provides businesses with the tools they need to improve the customer experience. It enables businesses to customize menus, process payments, and track customer behavior.
• Increase Revenue: OTC hospitality provides businesses with real-time insights into sales and inventory. It allows businesses to identify trends and make data-driven decisions that can increase revenue.
• Enhance Security: OTC Hospitalities is a secure system that encrypts all data. It ensures that customer information and payment details are kept safe.

Why Choose OTC Hospitality?

OTC hospitality is a cost-effective alternative to traditional POS systems. It does not require businesses to invest in expensive hardware, software, or maintenance. OTC hospitality is a cloud-based system that can be accessed from anywhere, at any time. The system is easy to use, and it provides businesses with real-time insights into their performance.

• Cost-effective: OTC hospitality is an affordable option for businesses looking to implement a POS system without breaking the bank.
• No expensive hardware: Unlike traditional POS systems, OTC Hospitalities does not require businesses to invest in expensive hardware.
• No expensive software: Hospitalities is a cloud-based system that eliminates the need for businesses to purchase and maintain expensive software.
• Accessible from anywhere: Because OTC Hospitalities is cloud-based, businesses can access it from anywhere, at any time, using a mobile device or computer.
• Real-time insights: OTC Hospitalities provides businesses with real-time insights into their performance, allowing them to make data-driven decisions that can improve their operations and increase revenue.

The Future of OTC Hospitality

OTC Hospitalities is rapidly gaining popularity in the Hospitalities industry. It is a cost-effective, easy-to-use system that provides businesses with the tools they need to streamline operations and improve the customer experience. As technology continues to evolve, OTC Hospitalities is likely to become even more advanced. In the future, we can expect OTC Hospitalities to offer even more features and functionalities that can help businesses to increase revenue and enhance the customer experience.

Case Study: OTC Hospitality in Action

One example of OTC hospitality in action is the success story of a small cafe in a busy city center. The cafe owner was looking for an affordable POS system that could help her to streamline operations and increase revenue. She chose OTC Hospitalities because it was easy to use, affordable, and provided real-time insights into her business’s performance. The system enabled her to customize menus, process payments, and track inventory in real-time. As a result, the cafe owner was able to increase revenue, improve the customer experience, and streamline operations.

Conclusion

In conclusion, the rise of OTC Hospitalities and its revolutionary impact on POS solutions has transformed the way businesses in the hospitality industry operate. By embracing cutting-edge technology and seamlessly integrating various systems, OTC Hospitality has empowered businesses to enhance customer experiences, streamline operations, and boost profitability. The robust features and functionalities offered by OTC Hospitality’s POS solutions have proven to be game-changers, allowing businesses to efficiently manage orders, inventory, payments, and analytics. As this industry continues to evolve, OTC Hospitalities stands at the forefront, constantly innovating and pushing the boundaries of what is possible. By embracing OTC Hospitality’s transformative solutions, businesses can unlock new levels of success in the dynamic world of Hospitalities.

It applies to all the member states of the EU and is in use for medicinal products intending for human use. Since its induction in 1995, the CP has become a mandatory requirement for biotechnological products. Including orphan medicinal products, and human products containing a new active substance intended for the treatment of specific diseases.

Mandatory Requirements for CP

In the EU before May 20, 2004, are subject to the mandatory requirement for CP. These products are intending for the treatment of AIDS, cancer, neurogenerative disorders, or diabetes. The CP is the only regulatory process that can be in use to obtain a marketing authorization for these types of products.

Optional Requirements for CP

Products that contain new active substances that were not in authorizing category in the EU before May 20, 2004. But do not fall under the above-mentioned categories, are not subject to the mandatory requirement for CP. Similarly, products that constitute a significant therapeutic, scientific, or technical innovation, and products that require community authorization in the interest of patients’ or animal health, may also be subject to the CP, but it is not mandatory.

Templarpharma’s Experience with CP

Templarpharma is a leading global regulatory solutions and services company that specializes in assisting generic medicinal product manufacturers through the Centralized Procedure (CP). We adheres to the requirements of submissions to Health Authorities (HAs) in the EU and supports the preparation of Product Development Reports.

Preparation for CP

To prepare for the CP process, a comprehensive dossier is compiled. It contains information about the medicinal product, including the active substance, its quality, safety, and efficacy. The dossier also includes details about the manufacturing process. The product’s labeling and packaging, and information about the pharmacovigilance and risk management systems that will be implementing.

Once the dossier is complete, it must be submit to the European Medicines Agency (EMA) for evaluation. The EMA is responsible for the scientific assessment of the medicinal product. The evaluation process includes a review of the dossier and any additional data that may be in request of the EMA or the member states’ regulatory authorities.

The submission of the dossier is a critical step in the CP process, as it contains all the information necessary for the EMA to make an informed decision about the safety, efficacy, and quality of the medicinal product. Therefore, it is crucial to ensure that the dossier is complete, accurate, and meets all regulatory requirements.

Evaluation and Approval

The EMA evaluates the CP, assessing the medicinal product with member states’ regulatory authorities. It reviews the dossier and additional data as needed. After evaluation, the EMA issues an opinion on safety, efficacy, and quality. The European Commission gives final approval.

Expert Guidance and Support

In summary, the Centralized Procedure (CP) is a regulatory process used to obtain a marketing authorization for medicinal products in the European Union (EU). It is mandatory for certain types of products and optional for others. Templarpharma has extensive experience in assisting generic medicinal product manufacturers. Through the CP process and can provide expert guidance and support in preparing dossiers. Also handling post-approval submissions and renewals, and ensuring compliance with regulatory requirements. If you require assistance with the CP process, contact Templarpharma today for expert guidance and support.

Expertise in Centralized Procedure

• Providing legal representation as a Marketing Authorization Holder (MAH) for medicinal product manufacturers who lack establishments in the European Economic Area (EEA).
• Regulatory consultation and strategic support during the developmental stage of medicinal products.
• Offering support in the selection of dissolution parameters, multimedia, and for performance of dissolution for both test products and Reference Medicinal Products (RMP).
• Preparation of Product Development Reports with consideration of the discriminatory nature of media.
• Designing specifications for finished products, API, in-process and intermediates.
• Providing advice on selecting Regulatory submission procedures based on the MAH’s requirements.
• Assistance with pre-submission administrative activities along with the Centralized Procedure.
• Advice for appointment/consultation of Qualified Person (QP) for quality, and Qualified Person for Pharmacovigilance (QPPV) for applicants outside EEA who lack their own QP and QPPV.
• Consultation for batch release testing site and batch control site testing if the applicants do not have their own sites in the EEA.
• Regulatory assessment and gap-analysis of source documents and already registered dossier for their regulatory adequacy.
• Compilation, technical review, finalization, publishing, and submission of Marketing Authorization Application (MAA) to EU Health Authorities (HAs).
• Preparation of regulatory strategy for responding to HA queries (RTQs).
• Preparation of responses to HA queries (HAQs) with supporting documents/data and scientific rationale to avoid delay in approval.
• Evaluation of change controls and supporting documents.
• Preparation of variation submission strategy.

Additional leverage

• Compilation and submissions of variations and renewals for MAA.
• Tracking renewal submissions for MAA and Centralized Procedure.
• Follow-up with regulatory agencies for the approval of the MAA.
• Assistance in the preparation of the Pharmacovigilance System Master File (PSMF).
• Preparation of Risk Management Plans (RMP) and Benefit-Risk Assessment Reports (BRAR).
• Preparation of pediatric investigation plans (PIP) and waivers.
• Regulatory support for clinical trials, including protocol preparation, clinical study reports, and regulatory submissions.
• Assistance in the preparation of Investigational Medicinal Product Dossiers (IMPD) and Investigational New Drug Applications (IND).
• Support in the preparation and submission of Annual Safety Reports (ASR) and Periodic Safety Update Reports (PSUR).
• Assistance in the preparation and submission of Orphan Drug Designation applications.
• Support in the preparation and submission of Scientific Advice Procedures.
• Regulatory intelligence and monitoring of changes in regulatory guidelines and legislation.
• Provision of training sessions and workshops for Regulatory Affairs.
• Assistance in the preparation of Standard Operating Procedures (SOPs) and Working Instructions (WIs).
• Assistance in the preparation of other regulatory documents and communications with regulatory authorities.

Investigational New Drug (IND) Applications are very crucial when conducting clinical trials with investigational drugs or drugs that are not approved for intended use, the sponsor must submit an IND Application to the US FDA and obtain Agency acceptance before the drug is transported or distributed across the US for use in the clinical program.

Importance of Adequate Information in IND Application

Inadequate information in the IND Application, including product quality, safety, and scientific evidence on proposed efficacy profile, can lead to a Clinical Hold issued by the US FDA. A Clinical Hold can restrict sponsors from moving forward until the issues are addressed.

Challenges in the IND Filing Process

Several challenges may arise during the IND filing process. Including identification of regulatory requirements, GMP/GLP compliance, product-specific scientific knowledge, managing clinical hold issues. Parallel planning of IND filing process, and managing ongoing CMC changes/protocol changes.

Identification of Regulatory Requirements for the IND Application

One of the most significant challenges in the IND filing process is identifying the regulatory requirements for the intended IND Application. This involves understanding the different phases of clinical trials and the associated regulatory requirements.

Managing Clinical Hold Issues

Sponsors must develop appropriate mitigation plans for potential clinical hold issues. This involves a comprehensive understanding of the clinical hold process and working closely with the FDA to address any concerns.

Templarpharma’s End-to-End Regulatory Support for IND Programs

Templarpharma provides end-to-end regulatory support for IND programs, starting from pre-IND meetings to regulatory compliance and management of late phase submissions when the IND goes effective. This includes managing ongoing CMC changes/protocol changes, safety reporting, annual reporting, and ensuring compliance with regulatory requirements.

Importance of Parallel Planning and Product-Specific Scientific Knowledge

Parallel planning of the IND filing process and other clinical trial-related logistics, such as clinical trial sites’ readiness, clinical material manufacturing & testing, and cGMP compliance at CMO sites, is critical to ensure a successful IND filing process. Additionally, product-specific scientific knowledge is essential to manage regulatory issues related to new chemical entities, biologics, radioactive labeled drugs, etc.

In conclusion, the IND filing process is a critical step in conducting clinical trials with investigational drugs or drugs not approved for intended use. The process involves several challenges, including identifying regulatory requirements, managing clinical hold issues, and ensuring product-specific scientific knowledge. Templarpharma provides end-to-end regulatory support to sponsors to ensure compliant IND filing and manage ongoing regulatory compliance throughout the clinical trial process.

Expertise in Investigational New Drug (IND) Applications

Generally offer a range of regulatory services to support clinical programs and IND submissions. Expertise includes identifying the optimal regulatory approach, providing regulatory support for pre-IND meetings and other agency communications. And assisting with requests for orphan drug designation and expedited review program designations.

Conduct a gap analysis of IND developmental data against current federal regulatory requirements to identify potential clinical hold issues and provide expert advice on regulatory mitigation plans for any identified data deficiencies or clinical hold issues.

Team has an extensive understanding of NDA/BLA submission requirements and data correlations from IND. To facilitate future Marketing Authorization Applications.  prepare, technically review, and submit CMC, non-clinical. And clinical packages for initial IND submissions, IND amendments, safety reporting. And IND annual reports submission in the eCTD format for various medicinal products such as new chemical entities. Including vaccines, biosimilars, and other biological products including tissue and gene therapy products.

Also provide IND submission templates in the eCTD format. As well as publishing and eCTD submission of initial INDs and subsequent submissions (IND annual reports, amendments, etc.). Regulatory response strategy ensures timely submission of responses to US FDA queries and information requests. Consulting support includes assistance with IND inactivation or re-activation, as well as US agent services.

Regulatory affairs is a crucial function in life sciences, consumer pharma, and bio-medical companies. It involves ensuring that products are developed, manufactured, and marketed in compliance with local and international regulations and standards.

In these companies, regulatory affairs professionals work closely with cross-functional teams to develop and execute regulatory strategies. They are responsible for compiling and submitting regulatory submissions to regulatory authorities. Such as the FDA and EMA, and for ensuring that all necessary documentation is complete and accurate. They also monitor and interpret changes in regulations and standards and advise the company on how to remain compliant.

Regulatory affairs professionals play a key role in obtaining regulatory approval for new products and maintaining compliance for existing products. They work closely with research and development teams to ensure that products are developed in compliance with regulations and standards from the start.

In addition, regulatory affairs professionals are involved in post-market surveillance activities, including monitoring and reporting adverse events, and in maintaining product labeling and promotional materials. They also provide guidance to internal teams on regulatory requirements and ensure that the company is informed of any changes in regulations and standards that may impact the company’s products or operations.

In summary, regulatory affairs is a critical function in life sciences, consumer pharma, and bio-medical companies that ensures compliance with regulations and standards, helps obtain regulatory approval for new products, and maintains compliance for existing products.

Templarpharma expertise in Regulatory affairs

• Submission Forecast and Planning
• Submission Document Management and Tracking
• Regulatory Content Management
• Change Control Management
• Label Change Tracking
• Integrated Regulatory Information
• Regulatory Intelligence
• Reporting and Analytics

Regulatory Consulting/Strategic services

Regulatory consulting and strategic services play an important role in helping life sciences, consumer pharma, and bio-medical companies navigate the complex regulatory landscape. These services provide expert advice and support to companies seeking to develop, manufacture, and market products that comply with local and international regulations and standards.

In addition, regulatory affairs, consulting firms offer support for regulatory compliance. Including monitoring changes in regulations and standards and advising companies on how to remain compliant. They can also provide training and education on regulatory requirements to internal teams. Ensuring that companies are prepared to meet regulatory requirements.

Overall, regulatory consulting and strategic services play a critical role in helping life sciences, consumer pharma, and bio-medical companies navigate the complex regulatory landscape. These services provide expert guidance and support that can help companies develop and execute regulatory strategies that support business goals while ensuring compliance with regulations and standards.

On the route, some significant obstacles encountered are:

• Finding regulatory solutions to address drug development issues such as impurities, analytical, stability, container closure-related issues, and more.
• Strategizing and planning for managing massive workloads resulting from acquisitions or business integrations.
• Strategizing for global clinical trials during drug development.
• Planning regulatory affairs submissions with a limited amount of available data or anticipating regulatory risks.
• Overcoming challenges related to reference medicinal products when dealing with multiple markets.
• Formulating regulatory strategies for responding to Complete Response Letter (CRL) from Health Authorities (HA) or responding to HA queries.
• Planning strategically for introducing products approved in one region to other regulated markets (for example, from the USA to Europe or vice versa).

Templarpharma Expertise in Regulatory consulting

The following services are provided by Templarpharma consulting firm to assist life sciences, consumer pharma, and bio-medical companies in navigating the global regulatory landscape:

• Developing submission plans for various Regulatory applications across global markets.
• Providing CMC consulting support for the preparation and submission of Regulatory dossiers, including INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMF, ASMF, and IMPD.
• Offering regulatory compliance consulting to address agency queries and CRLs.
• Preparing and submitting Biological License Applications (BLAs)/MAAs for recombinant therapeutic proteins, vaccines, and other biological advanced therapy products, such as stem cells and tissue-based products.
• Developing regulatory submission strategies for launching drugs in new markets.
• Providing regulatory compliance consulting for the implementation of post-approval changes.
• Offering regulatory consulting for pre-submission interactions with Health Authorities (HAs).
• Conducting a competitor landscape evaluation and developing appropriate regulatory strategies/mitigation plans to support product registrations, including the use of expedited program requests.
• Providing regulatory affairs consulting for Orphan Drug Designation (ODD) applications and other expedited programs.
• Providing CMC consulting for Quality by Design (QbD) protocols and reports, as well as for the development of biosimilars/biological products.
• Offering regulatory affairs consulting for the development of combination products (Device + Drug/Biologic).
• Conducting CMC consulting evaluations of pharmaceutical excipients against the IIG database.
• Providing regulatory compliance consulting in defining tests/risk assessments for genotoxic impurities, elemental impurities, and other impurities.
• Offering CMC consulting and stability study requirements considering bracketing and matrixing concepts.
• Developing regulatory strategies and identifying Reference Medicinal Product (RMP) for global markets.
• Identifying submission processes in Europe and providing regulatory affairs consulting in the selection of the Reference Member State (RMS).
• Providing regulatory compliance consulting in responding to HA queries.
• Offering consulting support for changes in formulation/route of administration of drugs and the registration of dossier to Health Authorities (HAs), including 505b (2) and hybrid applications.