Innovator Drugs Regulatory Services - Overview
Emerging innovations in science and technology have opened new avenues for the development of several novel drugs and advanced therapies, intended for the treatment of various life-threatening diseases and health conditions. In recent decades, there has been a significant increase in incremental innovation and investments in the Biopharma sector towards research and the development of new drugs. Hence, it is expected that there will be a significant increase in the number of Investigational New Drugs (INDs), Investigational Medicinal Product Dossier (IMPDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biological License Applications (BLAs), under various therapeutic categories in future years. Applications are expected under various categories, including. anti-cancer drugs, precision therapies, tissue & stem cell-based therapies, and gene therapies. and so on.
Many innovator companies face delays in product registration and lose time due to a lack of proper understanding of the Regulatory requirements specific to their case. Without a proper Regulatory understanding and the right partner to aid them during the product development stage, companies often face difficulties in clearing Regulatory hurdles while registering new products. Sponsors may be required to generate additional data (including additional clinical studies) which leads to investments of money and effort and delays, too.
Therefore, support from the right partner during the product development stage is the key to the successful registration and commercialization of innovative pharmaceutical and biological products. Freyr is a global Regulatory company with extensive experience in product development and supports innovator drug developments for Biologics and Pharmaceuticals.
Innovator Regulatory Expertise
Innovator Drugs Regulatory Services - Expertise
- Strategic support in identifying the optimal Regulatory approach for CTA submissions and obtaining CTA approvals in multiple countries across the globe (US, EU, LATAM, MENA, Africa, APAC, etc.).
- Gap analysis of developmental/submission data against the current Regulatory requirements of different countries for CTA submission and expert advice on mitigation plans for identified Regulatory issues, submission risks, potential clinical hold issues, etc.
- Authoring, technical review, and submission of clinical trial applications for pharmaceutical products, vaccines, biosimilars, and other biological products for most countries.
- Preparation and submission of CTA amendments (CMC & clinical) and annual reports (wherever applicable).
- Regulatory response strategy, preparation, and on-time submission of responses to HA queries on CTA submissions.
- Follow-up with Regulatory agencies throughout the clinical trial process.
