Regulatory Strategy Consulting – An Overview
The most common challenges faced by the pharmaceutical industry are the optimal investment of time and money and effective Regulatory compliance initiatives to fulfill business goals. Expert Regulatory strategy consulting support and well-defined Regulatory affairs strategies are essential in dealing with challenges in product commercialization and the drug development process. Some of the key challenges faced en route include the following:
- 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 at the time of the submission or with anticipated Regulatory risks.
- Reference Medicinal Product (RMP)-related challenges when dealing with more than one (01) market.
- Regulatory strategies to submit a response to a Complete Response Letter (CRL) from Health Authorities (HAs) 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 Regulatory consulting partner is key to the successful commercialization of medicinal products. With a proven track record of keeping abreast of global market conditions and navigating customers through their unique Regulatory requirements, Freyr acts as a preferred Regulatory Affairs consulting services provider and strategic partner for global pharmaceutical and biotechnology companies.
Regulatory Strategy Consulting – Freyr Expertise
- Submission planning for various Regulatory applications in the global market.
- Regulatory compliance consulting to address agency queries and CRLs.
- Preparation and submission of Biological License Applications (BLAs)/Marketing Authorization Applications (MAAs) for recombinant therapeutic proteins, vaccines, and other biological advanced therapy products such as stem cells and tissue-based products.
- CMC consulting support in the preparation and submission of Regulatory dossiers like INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMF, ASMF, IMPD, etc.
- Regulatory submission strategy for drug expansion in another market.
- 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.
- Pharmaceutical Regulatory consulting services for entering new markets.
- 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 assessments for genotoxic impurities, elemental impurities, etc.
- CMC consulting and stability study requirements considering bracketing and matrix concepts.
- Regulatory strategy and identification of RMPs for the global market.
- Identifying the submission process in Europe.
- Regulatory affairs consulting in the selection of Reference Member State (RMS).
- 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 HAs (for example, 505b (2), hybrid applications, etc.).
Regulatory Strategy Consulting – Freyr Advantages
- Experts who are up to date with the Regulatory changes.
- Compliance with the Regulatory requirements of global HAs.
- Experienced pharma Regulatory consultants.
- Designing the ideal Regulatory affairs strategy.