We are committed to accelerating the development and marketing of medical and health products for the benefit of patients. We can provide registration and regulatory consulting services covering the whole life cycle of medical and health products, including pharmaceutical products (small molecules, biologicals and natural products), medical devices, diagnostics and dietary supplements. Our services cover China, the United States, Canada, and major countries and regions around the world.
Our regulatory experts have more than 20 years of experience with a thorough understanding of the evolving local regulatory environment and comprehensive product development expertise, good communication with the regulatory authorities. We aim to accelerate the process of bringing products to market smoothly and efficiency with correct develop plan, appropriate regulatory strategy and high quality dossier.
We provide a range of registration and regulatory consulting services, including but not limited to:
Regulatory consulting:
- Consultant of product development and registration
- Feasibility assessment
- Regulatory strategy and plan
Medical and health products registration:
- Dossier writing and gap analysis
- Package compilation and publish (including eCTD)
- Regulatory Agent / Regulatory Contact Services
- Investigational Applications (Pre-IND, IND, Pre-Submission requests, IDE, ITA, CTA.)
- Marketing Applications （Pre-NDA , NDA, BLA, ANDA, 510K, DeNovo 510(k), PMA, MAA,)
- Drug Master Files
- Post Marketing Submission
- Supplements
- Orphan drug designation
- Fast track designation
- Breakthrough therapy designation
- Pediatric investigational product applications (PREA, PIP)
- Scientific avice submission
- Annual reports
- Trial registration
