Biologics

/ Biologics

Overview

Maven provides support for various types of biological medicinal products that include but are not limited to the following:

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
Assessment of data generated 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
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

Cost-effective
End-to-end Regulatory consultation
Qualified team of experts with hands-on experience across all categories of Pharmaceuticals (Generics & Innovator Drugs), Biologics (Biosimilars & Vaccines)
Expert support for region-specific Regulatory complexities
Interactions with Health Authorities (HAs)
Structured approach to ensure quick product launch or market access