GMP Pilot Plant

• Setup and development of analytical methods • Analytical support to formulation and process studies • QC testing of batches involved in in-vivo studies and supervision of bioanalysis • QC Testing of GMP batches • Microbiology (monitoring of GMP Pilot Plant) • Non-G...

• Supervision of IBs, protocols and related documents • Initiation and follow-up of clinical trials • Selection and contact of CROs

• Compatibility studies and preformulation • Formulation and lab-scale batches • Definition and supervision of in-vivo studies • Non-GMP and GMP activities • Med-Tech workshop for device prototyping

• Overall QA system • Internal and external audits

• Supervision of GMP activities • Release of GMP and clinical batches • Relationship with agencies • Consolidation and maintenance of regulatory documents