Country-Specific Regulatory Services - Overview
Freyr provides comprehensive support to ensure that your products meet local Regulatory standards and achieve successful approvals through interactions and follow-ups with HAs on ever-evolving country-specific Regulatory requirements and regular dialogue to clarify the technical content, which helps expedite the review and approval. Our country-specific Regulatory services are designed to help you meet these unique requirements and ensure compliance across all target markets.
Our country-specific Regulatory Services include:
- Legal/Local Representation Services
- Translations Services
- Module 1–Administrative Services
Country-Specific Regulatory Services
- Provision of legal/local representation to comply with local Regulatory requirements
- Accurate translation of Regulatory documents to meet local language requirements
- Ensuring compliance with the regional guidelines for document submission
- Regular updates on Regulatory guidelines
- Regulatory experts with fluency in the local language to interact with Health Authority Regulatory bodies
- Prepare or review a complete dossier to meet country-specific requirements
- Preparation of Module-1 documents in the local language with scientific inputs
- Presence of established offices and Regulatory experts in each Regulatory region to handle legal or local representation for all health authorities across the globe
- A complete understanding of the ever-changing Regulatory requirements of each health authority
- Regulatory experts with real-time experience in meetings/interactions with HAs
- In-depth knowledge of country-specific Regulatory requirements
- Translation services by qualified scientific translators to meet regional language requirements
- End-to-end management of country-specific Regulatory submissions
- Facilitating timely and successful product approvals