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We deliver a broad range of regulatory and consulting services for pharmaceutical companies. These services include: - Facility auditing: Contract Facility; Internal Audits/Compliance Inspections; Outsourcing; Design review; Vendor/Supplier audit;
- cGMP auditing of data, laboratories/facilities and procedures;
- Manufacturing, packaging, and shipping documentation of drug products review and approval for clinical trial;
- FDA, EU, HPFBI, JP (Pharmacopeias) guidelines and regulations;
- GMP: Good Documentation Practices;
- Necessary support for the conduct of clinical and safety assessment programs in accordance with all applicable country specific regulatory release requirements ( Eudralex EU Directives, Title 21 of the CFR (Code of Federal Regulations (USA) and Health Canada Directives).
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