Global Compliance & Validation Expertise
Maven’s Compliance and Validation Centre of Excellence (CoE) supports pharmaceutical, biotech, genomics, chemical, and medical device companies in meeting global quality, safety, and regulatory standards. Our audits cover cGMP, GCP, GDP, GLP, CSV, and GPVP practices.
Regulatory Compliance Services
We assess your current practices and recommend improvements to ensure compliance and customer satisfaction. Our audit preparation methodologies help avoid regulatory observations through gap analysis and CAPA recommendations.
Audit Capabilities
- 700+ preliminary checks across 18–19 GMP functional areas
- API audits and CMO audits
- Intra-company auditing
- Data integrity assessments
- Pre-inspection preparation (MHRA, FDA, EMA, ANVISA, ISO)
- GMP/GDP remediation audits
- Packaging and medical device audits
- Halal & Kosher audit facilitation
Compliance Standards Covered
- cGMP: Quality & Regulatory compliance
- ISO 9001:2015 QMS
- US FDA 21 CFR 820
- EudraLex Volume 4 GMP Guidelines
- CE Certification
- Health Canada GMP
- PIC/S GMP Guide
- WHO GMP for APIs
- ISO 13485:2016 for Medical Devices
- SFDA GMP Guidelines
- ICH Guidelines
Advantages
- Cost-effective, end-to-end regulatory consultation
- Expert team with hands-on experience across personal care and cosmetic categories
- Support for region-specific regulatory complexities
- Health authority interactions
- Structured approach for faster market access
