Pharma & Biotech Services
Welcome to our comprehensive suite of Pharmaceutical and Biotech services designed to support your journey through the complex landscape of medicines and biologics compliance and market access.
At Apotech, we offer a diverse range of solutions tailored to meet your audit, regulatory, quality, and operational needs. With frequent interaction with national competent bodies, and many of our consultants with experience within these organisations, Apotech brings first-hand insights and a personalised approach to support you in all international Pharmaceutical and Biotech requirements.
Auditing
At Apotech, we empower life sciences companies and manufacturers to achieve operational excellence via a range of comprehensive auditing services. Our onsite or remote audits help pharmaceutical and biotechnology companies maintain the highest standards of quality and safety. Apotech can support you in the following auditing areas:
- GCP
- GLP/GCLP
- GVP
- GMP
- GDP
- CSV
Quality Assurance
Building and maintaining robust quality systems is essential for pharmaceutical and biotech product integrity and patient safety. We understand the critical importance of maintaining the highest standards in quality, compliance, and efficiency within your operations. Our experienced team is dedicated to assisting organisations in developing robust QMS solutions to ensure regulatory compliance, streamline processes, and enhance overall performance. Our services cover:
- QMS Development
- Qualified Person (QP)
- Responsible Person
- Mock Inspections
- GxP Audits
- Training
Regulatory Affairs
Brining a medicinal product to market is an incredibly complex process. At Apotech, we have the skills and knowledge required to ensure complete regulatory compliance during both its clinical development and the entire project life cycle. Whether you’re in need of regulatory support during clinical development, or advice on post approval modifications, we can tailor our below services to support you in any way you need:
- Drug Development
- Medical Writing
- Global Submissions
- Life Cycle Management
Engineering
At Apotech, we offer specialised engineering solutions designed to meet the unique demands of the pharmaceutical and biotech industry. Our Engineering Services encompass a comprehensive spectrum of essential processes. Apotech can guide you through every stage of the design and development journey, from initial concept to successful commercialisation. Please see our services below:
- Commissioning, Qualification, and Validation (CQV)
- Process Validation
- Computer System Validation (CSV)
- Data Integrity
- Technology Transfer
Our Global Reach
We take pride in our extensive global audit network and are committed to utilising local auditors based in-country.
This approach offers several key benefits: local auditors possess in-depth knowledge of regional regulations, communicate effectively in the local language, and help reduce travel expenses for our clients. We have successfully provided support in all the regions highlighted on the map below.
Trusted by top-tier teams worldwide
