The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international co-operative arrangement between regulatory authorities that aims to harmonise GMP standards. PIC/S members include regulators across Europe, Asia-Pacific, the Americas, Africa, and the Middle East. RBridge Lifesciences supports dossier preparation and submission across PIC/S member countries.
What We Offer
- GMP Dossier Preparation, Clearance Support (New, Renewal, Line Extensions)
- Pathway Identification and Technical Evaluation
- Dossier Submission and Query Resolution
- Marketing Authorisation Maintenance
About PIC/S
- PIC/S currently has over 55 participating authorities worldwide
- Membership requires adoption of PIC/S GMP Guide (aligned with EU GMP)
- Mutual recognition of GMP inspections reduces duplication across member countries
- Products compliant with one PIC/S member's GMP requirements benefit from streamlined approval in others