Ascil Biopharm
About Ascil Biopharm
Certifications
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GMP
Categories
Products from Ascil Biopharm (6)
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Product Analytical and Phy-Chem Department
• 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... -
Product Clinical Department
• Supervision of IBs, protocols and related documents • Initiation and follow-up of clinical trials • Selection and contact of CROs
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Product Formulation, Process & Device Department
• 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 -
Product GMP Pilot Plant
• Manufacturing of pilot /scale-up batches • Manufacturing of GMP and clinical batches • Preparation of clinical kits
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Product QA Department
• Overall QA system • Internal and external audits
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Product QP, Tech Direction and Regulatory
• Supervision of GMP activities • Release of GMP and clinical batches • Relationship with agencies • Consolidation and maintenance of regulatory documents
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