Why Choose MIAS Pharma for Your GxP Audit or Audit Programme
- Experienced Audit Professionals: Our high-calibre auditors bring senior-level experience as former regulators and quality leaders within the pharmaceutical industry.
- Real-World Insight and Licensing Expertise: MIAS Pharma holds its own Manufacturing and Importation Authorisations (MIAs) for both the EU and UK. We understand what it takes to build and maintain a compliant GxP Pharmaceutical Quality System (PQS) and to effectively design and implement CAPA plans.
- Risk-Based, Practical Approach: We deliver audits that balance deep regulatory knowledge with actionable insights, ensuring the highest levels of compliance. Our high standards are recognised and respected by regulatory authorities.
- Flexible Global Delivery: With a trusted network of vetted partners worldwide, MIAS Pharma can deliver on-site audits across a wide range of site types and drug modalities at short notice.
Audit Support Across the Product Lifecycle
- Pre-approval Audits
- Investigational Medicinal Product Dossier (IMPD)
- Marketing Authorisation approval readiness
- Supply Chain Qualification or Requalification
- Mock Inspections (GxP inspection readiness)
Comprehensive Audit Coverage
MIAS Pharma conducts audits across a full spectrum of site types and product categories, including:
- ATMPs and Biologics
- Sterile and Non-Sterile Manufacturing (Drug Substance and Drug Product)
- Packaging and Lab Testing Facilities
- Importation Sites
- Packaging and Labelling Operations
- Quality Control and Analytical Laboratories
Flexible and Client-Centred Delivery
Our audit services are tailored to balance regulatory excellence with practical execution, and are available in formats to suit your operational needs:
- Conducted on-site or virtually
- Delivered by MIAS Pharma auditors or in collaboration with your internal QP/auditor team
- Available as standalone audits or as part of a broader audit programme
Your partner in quality, safety, and compliance
The life sciences sector requires specialized knowledge and reliable support. With our broad expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
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