QP & Responsible Person Services
QP certification of human and veterinary medicines including investigational medicinal products across a range of dose forms including tablets, capsules, powders, liquids, creams, steriles and metered dose inhalers. This service can be provided from within our group across EEA and the UK post Brexit.
RP Services to support customers own WDA requirements.
Quality Management System Support
- GAP analysis of existing Pharmaceutical Quality Systems.
- Implementation of new PQS for start-up companies or those new to pharmaceuticals.
- Assistance in remediation programs following adverse inspections.
- Use of own MIA and ManA for importation and release of human and veterinary medicines.
- Audits of manufacturing sites, packaging sites, distributors, API and raw material suppliers and contract laboratories.
- ISO9001 and ISO13485 audits.
- Management of audit programs.
From our in house team we can also provide:
- Initial Supplier review and assessment.
- Ongoing vendor management of the entire supply chain:
- API audits and certification.
- Raw material and packaging suppliers.
- Manufacturing and Packaging sites.
- Contract testing facilities.
- Distribution facilities.
- Pre-inspection gap assessments.
- Preparation and Management of Regulatory Inspections.
- RP services.
- Assistance with writing documentation for Pharmaceutical Quality Systems and managing those systems.
We provide help and support to all our clients to ensure they get it right.