Internal and External Audits
Pharma & Biotech Consulting has extensive international experience in conducting audits in the pharmaceutical, biotech, and medical device industries. Our comprehensive expertise enables us to conduct audits across various areas, including production, development, clinical studies, quality systems, analytics, wholesale, (parallel) import, and other services.
Our service includes not only the execution of audits but also the development and implementation of an effective action plan (CAPA management) to address identified weaknesses sustainably. In this way, we support you in efficiently implementing optimizations within your company and achieving long-term improvements.
Our audits are conducted in accordance with national (e.g., AMG, US-FDA, UK-MHRA) and international standards (e.g., EU/EWA, WHO, ICH) and are tailored to the specific requirements and regulatory demands of each industry. We offer audits for a wide range of areas, including pharmaceutical companies, biotech companies, wholesalers, (parallel) importers, raw material and active ingredient manufacturers, analytical laboratories, logistics providers, medical device manufacturers, software providers, and other specialized service providers.
With Pharma & Biotech Consulting as your partner, you benefit from a solution-oriented and proactive approach that helps you enhance compliance and efficiency. Thanks to our experience and precise methodology, we ensure that your internal and external audits are conducted professionally and meet all regulatory requirements.
Our Audit Focus and Industry Expertise
- Pharmaceutical companies
- Biotech companies
- Wholesale and (parallel) importers
- Raw material manufacturers
- Active ingredient manufacturers
- Analytical laboratories
- Logistics providers
- Medical device manufacturers
- Software providers
- Service providers