Health Authority interactions and Regulatory Intelligence Services

Health Authority interactions and Regulatory Intelligence Services

Health Authority interactions and pre-submission meetings are an essential part of the regulatory affairs process for life sciences, consumer pharma, and bio-medical companies. These meetings allow companies to present their plans and obtain feedback from Health Authorities (HAs) before submitting formal applications.

Effective communication with Health Authorities (HAs) plays a vital role in the successful development. And quick approvals, and uninterrupted commercialization of medicinal products. Upon receiving a specific application for review. HAs evaluate the submitted data and may request further clarification or express concerns regarding quality, safety, and efficacy to grant approval.

To address such concerns and to understand the HA requirements, Health Authority interactions and pre-submission meetings are crucial. These interactions provide an opportunity for applicants to explain their rationale and Regulatory strategy for their submission.

Templarpharma, a renowned Regulatory partner, has a team of ex-agency experts and senior industry professionals to assist sponsors with various types of agency meetings, including pre-IND, EOP, pre-NDA, pre-BLA meetings, etc. Our team has a strong track record of handling Health Authority interactions for different stages of development and navigating towards a successful outcome for Regulatory approval.

Templarpharma Expertise

  • We have a proven track record of securely communicating with Health Authorities (HAs). For various technical matters related to clinical, non-clinical, and CMC areas for future Regulatory submissions.
  • Our team evaluates sponsor developmental and scientific data to provide a strategy for HA interactions and pre-submission meetings during all stages of the product development life cycle.
  • We prepare pre-submission meeting requests for various Health Authorities across the globe, including Type A, B, C meetings with the US FDA, BPD meetings for biosimilars, pre-ANDA meetings for complex generics, scientific meetings with the EU, and pre-CTA meetings and NMC meetings with the rest of the world.
  • Our team also prepares meeting materials and briefing packages and manages any queries or information requests from the Health Authorities against pre-submission meeting requests.
  • We facilitate meeting preparations, rehearsals, and participation in Agency meetings, including face-to-face and teleconferences with sponsors and Marketing Authorization Holders.
  • In collaboration with our clients, we prepare meeting minutes and provide strategic support in implementing action items post-meeting.
  • Our in-house Regulatory experts. With real-time experience in research, analytical, manufacturing, clinical, and non-clinical areas, provide expert advice or guidance on Regulatory mitigation plans for identified deficiencies.
  • At our company, we aim to be the preferred Regulatory partner for sponsors worldwide by providing a comprehensive range of Regulatory services. That support drug development programs.

Regulatory Intelligence Services

Manufacturers of biopharmaceutical products face challenges in understanding. And decoding updated Regulatory compliance requirements due to the dynamic and stringent nature of Global Regulatory requirements. It is important for manufacturers to develop appropriate Regulatory strategies to enter global markets. A comprehensive Regulatory intelligence support is the ideal solution to overcome these challenges.

Regulatory Intelligence involves evaluating the Regulatory framework for targeted countries. Identifying regulations and Health Authority guidance, understanding the medicinal product approval process. Registration dossier submission requirements, and practical challenges during the application review and approval process.

Manufacturers can benefit from a detailed Regulatory Intelligence report that outlines product classification. And registration requirements, CMC, non-clinical, clinical, labeling, GMP requirements, and import regulations. This report will help them arrive at a Regulatory strategy to commercialize their product in the country.

Templarpharma has a proven track record in providing the best Regulatory intelligence support. And Regulatory submission strategies to help manufacturers commercialize their medicinal products across the globe. Our Regulatory experts have real-time experience in the following. Research, analytical, manufacturing, clinical, and non-clinical areas to ensure manufacturers meet all the Regulatory requirements.

Templarpharma Expertise

  • Templarpharma has a proven track record in supporting medicinal products manufacturers with the best Regulatory intelligence support. And Regulatory submission strategies to commercialize medicinal products across the globe.
  • Templarpharma offers strategic support in identifying the optimal pathway for different types of applications in the global market. (US, EU, Japan, Canada, Australia, and RoW).
  • Templarpharma provides ILAP (The Innovative Licensing and Access Pathway) consulting for the UK. And helps in identification of Regulatory compliance requirements and mitigation plans for the targeted countries.
  • The company offers intelligence on drug market-entry from one market to another and provides intelligence. For global clinical trial programs and large-scale product registration activities.
  • Templarpharma also offers competitors landscape evaluation to prepare the right Regulatory strategy for product registrations, product evaluation for suitability under expedited programs and Regulatory support for submission of expedited program requests (Fast Track designations, Breakthrough Therapy designations, Accelerated Approval process, and Priority Review designations).
  • The company has expertise in dealing with developmental issues with various types of medicinal products (biologics, small molecules, medical devices, combination products, etc.) and can provide developmental approach and Regulatory submission requirements for complex products.
  • Templarpharma helps in the identification of reference medicinal product as per the global commercialization plan and defining the right developmental approach and Regulatory submission roadmap.