We’re your trusted partner in every phase of pharma compliance and expansion.
GxP Audit Services
Carry out audits in all GxP-regulated areas—individually or as part of a shared audit.
Validation & Documentation Upgrades
Back-office support as well as on-site deputation to resolve audit observations and upgrade documentation.
EU, FDA & PIC/S Filings
Assist with EU, FDA and PIC/S applications through our network of international associates.
Conducting thorough audits sets a solid foundation for ensuring compliance and operational excellence. Our audits meticulously cover every critical area, leaving no stone unturned. Documentation integrity is vital for smooth regulatory compliance. Our dedicated validation teams collaborate closely with your staff, ensuring that every document meets global standards. We recognize the complexity of navigating international regulatory landscapes. With our robust global network, we streamline your regulatory filings efficiently and reliably.
Concept to commissioning
Complete engineering from concept to commissioning along with competent associates.
- Review project cost estimates, execution plans, and feasibility studies.
- Understanding the financial and operational feasibility of your project is crucial. Our in-depth analysis provides clear, actionable insights that guide confident decision-making.
- Provide PMC & EPCMVA (Engineering, Procurement, Construction Management, Validation & Approval) in partnership with expert engineering consultants.
Turnkey Facility Expansion
End-to-end expansion and upgrade of pharmaceutical manufacturing & testing facilities in Europe.
From initial planning to the final approval stage, our turnkey projects deliver fully equipped, compliant facilities designed specifically for your pharmaceutical operations.
Equipment Sourcing & Factory Acceptance Testing from India
Sourcing of specialized equipment and systems tailored to your operational needs. Conduct Factory Acceptance Tests on behalf of the buyer and issue a full FAT report.
Our rigorous testing ensures the reliability and performance of every piece of equipment you procure, safeguarding your investment and operational continuity.