Our Service Portfolio
QA/QC & EU GMP Compliance
EU GMP preparation, PICS pre-audit, and complete documentation review for regulatory compliance.
Turnkey Projects
Complete turnkey solutions including clean room design, machinery installation, and validation.
Regulatory Affairs
Pharmacovigilance, market authorization, and M&A support through our Croatian partner.
Technology Transfer
Process transfer, scale-up, and comprehensive operator training programs.
Clean Room Solutions
Professional design, installation, and full validation of clean room facilities.
Compliance & Auditing
Internal audits, gap analysis, and documentation review for continued compliance.
Service Details
Quality Assurance & EU GMP Compliance
Navigating the complex landscape of pharmaceutical regulations requires specialized expertise. We support manufacturers in achieving and maintaining EU GMP compliance through comprehensive preparation, implementation, and ongoing support services. Our team has extensive experience with EU regulatory bodies and understands the nuances of pharmaceutical manufacturing directives.
- Complete EU GMP preparation and implementation strategies
- PICS (Pharmaceutical Inspection Co-operation Scheme) pre-audit review and preparation
- Comprehensive documentation review and optimization
- EU auditor preparation and mock audit scenarios
- Post-audit follow-up and corrective action support
Turnkey Projects & Manufacturing Setup
Establishing a new manufacturing facility or upgrading existing operations is complex and requires deep industry knowledge. We provide end-to-end turnkey solutions that handle every aspect of your project, from initial consultation through full operational handover.
- Facility design and engineering consultation aligned with your production goals
- Clean room design, construction, and certification to ISO classifications
- Machinery selection, procurement, and installation from verified suppliers
- Commissioning, IQ/OQ/PQ (Installation/Operational/Performance Qualification)
- Comprehensive staff training and complete documentation packages
Regulatory Affairs & Market Authorization
Expanding to new markets requires navigating diverse regulatory frameworks and complex approval processes. Through our Croatian partners, we provide expert guidance and support across the entire market authorization lifecycle.
- Pharmacovigilance services and adverse event reporting
- Market authorization and regulatory filing support
- Market access strategy development and execution
- Mergers & acquisitions regulatory consulting
Technology Transfer & Process Scaling
Successfully transferring technology and scaling processes requires meticulous planning, technical expertise, and collaborative partnership. We work closely with your team to ensure smooth transitions and successful process scale-up.
- Detailed process documentation and transfer protocols
- Scale-up support and validation on larger equipment
- Comprehensive operator and technical staff training programs
- On-site technical support during critical phases