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.