Supply Chain
Ensure your product integrity and market continuity with our end-to-end supply chain expertise. We manage critical EU processes, including compliant Importation, QP Release, Warehousing, and provide essential roles like RP Services, alongside comprehensive Pharmacovigilance and Virtual GDP Setup. Trust us to mitigate risks and maintain full regulatory compliance from production site to patient.
MIA and WDA Licencing
We help you navigate the complex application processes for Wholesale Dealer Licenses and Manufacturing/Importation Authorizations, accelerating approvals.
Falsified Medicines Directive (FMD) Implementation
Achieve full compliance with EU Falsified Medicines Directive requirements. We establish verification systems, train personnel, and ensure your operations meet all serialization and authentication obligations protecting patients from counterfeit medicines.
Pharmacovigilance
We provide adverse event management, safety database maintenance, and complete pharmacovigilance system implementation for pharmaceutical and biotech companies across all markets.
Shipping Lane Establishment
Establish reliable pharmaceutical distribution routes with expert shipping lane design and implementation. We create compliant, efficient logistics pathways that connect your manufacturing sites to destination markets, regardless of your warehouse or third-party arrangements.
Qualified Person (QP) Services
Our experienced QP professionals certify your pharmaceutical products meet all quality and regulatory requirements before distribution across European markets.
Importation and Warehousing
We help you set up your supply chain by securing temperature-controlled facilities, experienced importation teams, and Qualified Person services ensure product integrity from customs clearance through distribution.
Vendor Qualification
Strengthen your pharmaceutical supply chain integrity through comprehensive vendor qualification. Our GDP-compliant assessment services identify reliable partners, mitigate supply chain risks, and ensure every vendor meets stringent regulatory and quality standards.
Audit Services
We conduct thorough internal and external audits to assess GDP compliance and identify improvement opportunities, while delivering targeted training programs that build staff competence and strengthen your quality culture.
Responsible Person (RP) Services
Our Responsible Person services ensure compliance, facilitate market access, and provide the regulatory oversight your organization needs to operate successfully across European markets.
Quality Management Systems
Accelerate your market entry and regulatory approval with expert Quality Management System implementation. We deliver compliant, scalable QMS solutions that reduce time-to-market while protecting your operational investment and reputation.