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. Once API/Excipient information is filed with HAs and is accepted, same can be referred through Letter of Access (LoA) to multiple applications to avoid duplication of API information for different drug product submissions.
Regulatory submission requirements for API (Drug Substance)/ Excipients are very specific and different for every HA. Hence, expertise and experience in filing DMFs, ASMFs, CEPs, and active ingredient master files to global HAs help in quick review approval of drug product applications. Freyr has very strong Regulatory team with expertise in handling new submissions to all major HAs like, the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM), the Therapeutic Products Database (TPD), the Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA), Med Safe, the Medicines Control Council (MCC), Ministry of Health (MoH) of Russia, Latin America (LATAM), Middle East and North Africa (MENA), Asia Pacific (APAC), Association of Southeast Asian Nations (ASEAN), Commonwealth of Independent States (CIS) regions, and the World Health Organization (WHO).
With a strong footprint in handling all types of API/Excipient initial submissions to global countries including chemical and fermentation, sterile and for biologicals, Freyr is proven to be a preferred Regulatory partner across the globe.
To evaluate the safety and suitability of information submitted with DMFs, HAs mandated that the DMF is filed using an electronic Common Technical Document (eCTD). Thus, the HAs can fast track the processing, reviewing, and archiving of submissions. Ensuring the same is practiced, the United States Food and Drug Administration (USFDA) has set forth deadline for DMF eCTD submissions, i.e. 05/05/2018, post which submissions will not be received.
Regulatory Documents/Dossier - Strategy, Gap Analysis, Compilation, Regulatory Writing and Submissions of following application types
- DMF submission in line with the GDUFA requirements to the USFDA for APIs/Excipients
- DMF in line with other global HA requirements for APIs
- ASMF submission in line with the European requirements for APIs
- CEP Application to European Pharmacopoeia to EDQM for APIs
- API Master Files/Global Health Authorities
- Investigational Medicinal Product Dossier (IMPD)
- Market Authorization Applications (MAA)
Freyr Regulatory Consultation and Pre-submission Support
- Identifying the Regulatory starting material and route of synthesis for drug substance and excipient
- Designing of specifications for starting materials, raw materials, excipients, packing materials, in-process, intermediates and drug substance/excipient
- Setting the strategy and limits for genotoxic impurities and elemental impurities
- Support in finalization of stability protocol, process validation protocol, hold time study protocol, degradation study protocol and analytical method validation protocol and review respective reports for submission
- Gap analysis of submission batch documents
- U.S./Canada agent services
- Pre-assigned DMF number request
- Establishment registration self-identification i.e. D-U-N-S number and FEI number request
- DMF/ASMF/CEP publishing in eCTD/NeeS/PDF as per current guidelines and requirements
- Addressing HA queries in stipulated timeframe for quick approvals
- Experienced Regulatory professionals to provide the end-to-end Regulatory support from development stage to registrations and approvals for drugs and other products
- Expertise in handling pre-submission administrative activities
- Regulatory submission strategies for product rollouts and expansions to other regions
- Regulatory professionals with experience in compilation and submission
- Accurate scientific justifications for HA query response