Pharmaceutical Regulatory Affairs Services – An Overview
Pharmaceutical Regulatory Affairs services are important in the successful registration of medicinal products intended for human use with different Health Authorities (HAs). The role of these services is to navigate the dynamic requirements set forth by each HA, ensuring compliance and smooth approval processes.
The professionals in the Pharmaceutical Regulatory Consulting Services team possess a comprehensive understanding of the submission requirements and stay updated with all the changes. Their knowledge and experience in Pharma Regulatory affairs consulting are vital in effectively managing Regulatory submissions, preventing rejections, and ensuring timely approvals.
Freyr, a trusted consultant in the field of Pharmaceutical Regulatory Affairs services, has been assisting numerous global manufacturers with their Regulatory submissions. Considering end-to-end pharmaceutical Regulatory consulting services, Freyr offers comprehensive support to medicinal products’ sponsors. Our experts help customers in ensuring that all necessary documentation and information are evaluated and submitted accurately.
Pharmaceutical Regulatory Affairs Services – Freyr Expertise
- Regulatory submission road maps/strategic reports for the identified medicinal products.
- Offering end-to-end Pharmaceutical Regulatory affairs services during product development.
- Pre-submission technical meetings with the USFDA/EMA/other HAs.
- Correspondence with the global HAs for product registrations and approvals.
- Support for the finalization of the composition of the medicinal products.
- Designing of submission specifications.
- Guidance in the preparation of protocols/reports for product development, process validation, exhibit batches, hold-time studies, and stability studies.
- US/Canada local agent support.
- Support for all pre-submission administrative activities.
- Technical gap analysis of the supporting documents/data.
- Guidance on additional/missing documents/data generation to mitigate the gaps.
- Authoring and reviewing CMC modules for initial submissions like INDs/IMPDs/CTAs.
- NDAs-505(b)2/Dossiers/BLAs for innovator pharma/biologics/biosimilars/vaccines.
- Authoring and reviewing CMC modules for initial submissions like ANDAs/ANDSs/MAAs/Dossiers and DMFs for generic products.
- Change-control evaluation and preparation of submission strategy.
- Preparation of CMC packages for post-approval change submissions like supplements/variations/amendments.
- Preparation of CMC packages for lifecycle management submissions like Annual Reports/Renewals.
- Handling HA queries and preparation of response packages.
Pharmaceutical Regulatory Affairs Services – Freyr Advantages
- End-to-end Pharmaceutical Regulatory affairs services.
- Experienced Pharma Regulatory consultants.
- Offering Pharmaceutical Regulatory consulting services support in submission activities.
- Proven expertise in Regulatory Affairs in pharma.