The appropriate and timely communication with Health Authorities (HAs) is a key factor for the speedy approval and uninterrupted commercialization of a medicinal product either during initial approval or during Life Cycle Management (LCM, i.e. through post approval changes submissions).
Regulatory assessment is a key activity in registration and life cycle maintenance of Pharmaceutical and Biological products. It is important at various stages of product development such as: prior to Regulatory submission, during review and approval and post-approval of the product for global markets.
Freyr is a leading player in Centralized Chemistry, Manufacturing and Controls (CMC) and dossier life cycle management, offering services ranging from strategy consulting for CMC/legacy product life cycle management (LCM) delivery models (centralized), and operational outsourcing of CMC/life cycle activities. Freyr has an established Center of Excellence for Regulatory CMC and life cycle management – offering Regulatory support for hundreds of products of Top-20 Pharma/Consumer Healthcare companies.
Filing Active Pharmaceutical Ingredient (API)/Excipient information separately to Health Authorities (HAs) is not mandatory. However, to maintain the confidentiality and to refer the same information for multiple drug product applications, as a practice, manufacturers of API/Excipients file the information as Drug Master Files (DMFs), Active Substance Master Files (ASMFs), and Certificates of Suitability (CEPs) as per the region-specific requirements.
To commercialize a product in a specific region, organizations must obtain market authorization from target country’s Health Authority (HA), which can be processed by filing an initial submission application (viz. Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Clinical Trial Application (CTA) and other regional applications etc.).
Global Dossier Management implicates tasks that are driven under strict timelines coupled with coordination across local markets in order for companies to expand their prospects in several geographies. The information that is usually distributed throughout huge volumes of country specific source documents seems to be a real-time challenge for companies during compilation. Multiple manufacturing sites further add to impediments in global harmonization which eventually affects the publishing lifecycle.
A South Korea based, global Pharma company, was filing information on APIs to the agency as cross reference to NDA and ANDA submissions. The DMF submissions required were for North America, Latin America and Canada. The major bottleneck to get through this project was to acquire sound knowledge on CA eCTD M1 specifications.
Download this case to get details on Freyr’s global delivery model for successful DMF submissions within one week.
A UK based pharmaceutical company was engaged in filing detailed information on the active pharmaceutical ingredients (API) to the agency for the cross reference to Marketing Authorization Application (MAA). The primary target was to file an ASMF in eCTD format through gateways and the challenge was to go through various national submission procedures such as, CP, DCP, MRP, and NP.
Read more on how Freyr assisted the organization reaching out to the Europe region with streamlined ASMF submissions within 2 weeks.