Regulatory Services
At B.J.Pharmachem, we offer comprehensive Regulatory Affairs services to help our clients navigate the complex and ever-changing global regulatory landscape. Our expert team provides end-to-end support, from dossier preparation to product registration and post-approval maintenance, ensuring full compliance with regulatory requirements in both domestic and international markets.
- Our Regulatory Services Include:
- CTD / ACTD / eCTD Dossier Preparation
- Preparation of Common Technical Documents (CTD), ASEAN CTD, and electronic CTD formats in line with global regulatory standards (WHO, USFDA, EMA, TGA, etc.).
- Product Registration Support
- Complete assistance in submitting documents and securing market authorization approvals from various health authorities.
- Country-Specific Regulatory Compliance
- Tailored documentation and support as per specific country guidelines across Asia, Africa, Latin America, CIS, and the Middle East.
- Labeling & Packaging Review
- Ensuring that product labeling meets the specific legal and linguistic requirements of the target market.
- Regulatory Strategy Consulting
- Strategic advice for global product launches, regulatory pathway planning, and lifecycle management.
- Why Choose Us?
- Experienced regulatory team with knowledge across multiple regulatory jurisdictions.
- Proven track record in over 50+ international product registrations.
- Quick turnaround time and ongoing post-approval support.