One partner across the entire lifecycle. Consulting that delivers.

Instead of separate specialist firms for each phase, one permanent team that delivers on the regulatory and operational side, from first classification to post-market surveillance.

Hands-on support across the entire lifecycle, from drug substance research to GDP-compliant distribution. On the ground, from the shop floor to the authority dossier.

• EU GMP Annex 1: contamination control strategies and sterile manufacturing
• Inspection readiness and mock audits for FDA and EMA inspections
• CSV and data integrity per GAMP 5, ALCOA+ and 21 CFR Part 11
• Tech transfer and scale-up with process validation (PPQ)

From biomedical research to industrial GMP manufacturing: scale-up from lab scale to commercial production of biologics, with complete process characterization and CMC documentation.

• Bioprocess development and scale-up: CPPs/CQAs, DoE, PPQ
• ATMP and cell/gene therapy: GMP manufacturing and EMA/FDA approval
• CMC for biologics and biosimilars per ICH Q5, Q6B, Q8-Q12
• GDP-compliant cold-chain logistics for temperature-sensitive products

From product development to post-market surveillance: the EU MDR translated pragmatically into day-to-day development, for a time-critical, audit-ready market access.

• EU MDR (2017/745), CE marking and legacy device transition
• Design controls and usability per IEC 62304 and IEC 62366
• Clinical evaluation (CER) per MEDDEV 2.7/1 Rev. 4 and PMCF
• Risk management per ISO 14971, biocompatibility per ISO 10993

Through the IVDR paradigm shift in clinical evidence and performance evaluation: from assay development to the post-market phase, including portfolios with 200+ products.

• IVDR (2017/746): reclassification per Annex VIII and transition
• Performance Evaluation Reports (PER), especially class C and D
• Companion diagnostics: alignment between IVD, pharma and authorities
• EUDAMED registration, UDI, post-market surveillance and PSUR