One of the most common challenges faced by the biopharmaceutical industry is the optimal investment of time and money, and effective Regulatory compliance initiatives to fulfil organizational business goals. Expert Regulatory consulting support and well-defined Regulatory strategies become essential factors in dealing with challenges in the product commercialization aspects and throughout the drug development process as well. Some of the key challenges faced en route include:
- Regulatory way-outs to resolve drug developmental issues (impurities, analytical, stability, container closure-related issues, etc.).
- Regulatory strategy and planning of huge work volumes triggered due to acquisitions/ business integrations.
- Strategic planning for a global clinical trial during drug development.
- Strategic planning of Regulatory submissions with minimum available data by the time of submission or with anticipated Regulatory risks.
- Reference medicinal product-related challenges when dealing with more than one market.
- Regulatory strategies to submit a response to CRL (Complete Response Letter) from Health Authorities (HA) or response to HA queries.
- Strategic planning to take the products approved in one region to other regulated markets (for example, from the USA to Europe or vice versa).
Therefore, the right partner for Regulatory consulting is the key to the successful commercialization of medicinal products. With a proven track record to keep abreast of the global market conditions and navigating clients through their unique Regulatory requirements, Freyr acts as a preferred RA consulting and strategic partner for any pharmaceutical or biotechnology companies.
- Submission planning for various Regulatory applications in the global market.
- CMC consulting support preparation and submission of Regulatory dossiers like INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMF, ASMF, IMPD, etc.
- Regulatory compliance consulting to address agency queries and CRLs .
- Preparation and submission of Biological License Applications (BLAs)/MAAs for recombinant therapeutic proteins, vaccines, and other biological advanced therapy products such as stem cells and tissue-based products.
- Regulatory submission strategy for drug launch from one market to another.
- Regulatory compliance consulting for the implementation of post-approval changes.
- Regulatory consulting for pre-submission interactions with HAs.
- Competitors landscape evaluation and preparation of the right Regulatory strategies/mitigation plans that suit product registrations ahead of using expedited program requests.
- RA consulting for Orphan Drug Designation (ODD) applications and also other expedited programs.
- CMC consulting for Quality by Design (QbD) protocols and reports.
- CMC consulting for the development of biosimilars/biological products.
- RA consulting in dealing with developmental issues of a combination of products (Device + Drug/ Biologic).
- CMC consulting for evaluation of pharmaceutical excipients against the IIG database.
- Regulatory compliance consulting in defining the tests/risk assessment for genotoxic impurities, elemental impurities, etc.
- CMC consulting and stability study requirements considering bracketing and matrixing concepts.
- Regulatory strategy and identification of Reference Medicinal Product (RMP) for the global market.
- Identifying the submission process in Europe.
- Regulatory affairs consulting in the selection of RMS (Reference Member State).
- Regulatory compliance consulting in providing a response to HA queries.
- Consulting support for change in formulation/route of administration of drugs and the registration of dossier to Health Authorities (HAs) (for example, 505b (2), hybrid applications, etc.).