End-to-End Regulatory Affairs Services
At RABT Global, we offer proficient regulatory affairs services for the pharmaceutical and medical device industries. Our seasoned experts ensure full compliance and streamlined processes—from development to post-marketing.
Product Registration & Submissions
Preparation and regulatory submission of dossiers for NDAs, ANDAs, PMAs, and 510(k)s to obtain marketing authorizations.
Clinical Trial Support
Design and implement clinical trial strategies ensuring regulatory compliance, safety, and efficacy for your product pipeline.
Quality Management Systems
Establish quality systems aligned with GMP and conduct audits to identify and address potential compliance gaps.
Labeling & Packaging Compliance
Ensure labels meet all guidelines—usage instructions, warning labels, and correct language translations for global markets.
Post-Marketing Surveillance
Assist with product monitoring, adverse event reporting, and variation submissions per regulatory authority mandates.
Regulatory Intelligence
Stay ahead with intelligence services that track evolving regulations, guidelines, and authority expectations worldwide.
Medical Devices
- Product classification
- Product documents evaluation
- Compilation of Technical file | Dossier, and submission
- CE Technical files submission, 510k
- Local Representative or Authorized holder services
- Translation services
Pharmaceuticals
- Regulatory Strategy and Consulting
- Regulatory Quality Support
- Regulatory Intelligence
- Interaction with Regulatory Health Authorities
- Translation services
- Toxicological services (PDE, HBEL)
- Publishing Management
- Product Life Cycle Management
- Labeling & Artworks
