Tatiana MatveevaPharmaceutical Quality, Regulatory CMC & GMP Consulting
RegCompliance is an independent consulting practice supporting pharmaceutical and biotechnology organisations in Regulatory CMC, Quality Assurance and GMP compliance.We provide practical, risk-based support across product development, global submissions, quality systems, CDMO oversight, product lifecycle management, data integrity and inspection readiness.Based in Basel, Switzerland. Engagements are available remotely and on site, subject to project requirements.
SERVICES
Regulatory CMC & Submission Support
Strategic and operational support for CMC documentation, lifecycle activities, variations and health-authority interactions.Quality Systems & GMP Compliance
Support for quality systems, investigations, CAPA, change control, data integrity and inspection readiness.CDMO & Supplier Oversight
Support with CDMO due diligence, supplier qualification, quality-agreement review, audit preparation and compliant governance.Project & Remediation Support
Independent cross-functional support for complex quality and regulatory projects, gap assessments and remediation initiatives.
Contact
For independent consulting support in Pharmaceutical Quality, Regulatory CMC and GMP compliance, please get in touch: