Ensuring Regulatory Integrity and Product Safety
BQCIS conducts comprehensive inspections for pharmaceutical production sites, sterile medical device manufacturing facilities, and laboratories to verify compliance with international Good Manufacturing Practice (GMP) standards.
Our specialists perform on-site facility assessments, cleanroom inspections, environmental monitoring, and product verification against ISO 13485, FDA 21 CFR Part 820, and WHO GMP guidelines.
From active pharmaceutical ingredient (API) verification to packaging and sterilization validation, we help ensure patient safety and supply chain transparency for regulated products.
Our Pharma & Medical Device Inspection Activities
Key Benefits of Pharma & Medical Device Inspection
Ensure Patient Safety
Comprehensive GMP and quality inspections safeguard end-users against defective or contaminated products.
Maintain Regulatory Compliance
Audits and verifications aligned with FDA, EMA, and ISO 13485 help sustain export approvals.
Enhance Supply Chain Integrity
Independent oversight ensures traceability from raw materials to finished batches.
Build Market Confidence
Third-party certification improves reputation with regulators, investors, and healthcare providers.
Success Story
BQCIS Enables EU GMP Certification for a Vaccine Producer
A biopharma company in Africa required EU GMP certification to export vaccines to Europe but lacked internal audit capacity.
BQCIS conducted a full GMP pre-audit, reviewed quality documentation, validated sterilization processes, and trained QA personnel.
The facility achieved EU GMP compliance within six months, enabling exports valued at $8.4 million annually.