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, gene therapies. and so on.
Many innovator companies face delays in product registration and lose time due to a lack of proper understanding on 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 require to generate additional data (including additional clinical studies) which lead to investments of money and effort and delays, too.
Therefore, support from the right partner during the product development stage is the key to a 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.
- Regulatory strategies and route maps for development & registration of innovator products
- Expert advice on mitigation plans for product developmental issues/ submission risks
- Monitoring of developmental programs on a periodic basis and assisting clients with Regulatory support, wherever needed
- Evaluation of developmental data and Regulatory gap assessment to identify the anticipated Regulatory issues (submission risks) as per the therapeutic category and manufacturing methods involved in drug development and manufacturing (e.g. rDNA technology based products, gene therapy products, stem cell products, immunotherapies etc.)
- Complete support in pre-submission interactions with Regulatory agencies
- Competitors landscape evaluation and preparation of the right Regulatory strategies that matches product registrations
- Support in Orphan Drug Designation applications
- Product evaluation for suitability under expedited programs for serious conditions; and Regulatory support for submission of expedited program requests to US and EU Regulatory agencies.
- Regulatory submission services for new innovations and proprietary technologies, including, Master File services, and the Identification of Regulatory route maps for submission information about process, methods and other advanced technologies, like gene sequencing techniques, that are proprietary in nature
- Guidance on the designation of specifications for active substance, finished product, in-process controls, intermediates
- Consulting in defining the limits for genotoxic impurities and elemental impurities