Basic Pharma Manufacturing

Basic Pharma Manufacturing

Basic Pharma can bring your pharmaceuticals from lab scale to the early clinical phase and beyond. Our state-of-the-art facility, with GMP-compliant clean rooms, is well equipped to offer a wide range...

About the plant

Manufacturing, testing and distribution of investigational medicinal products (IMPs) is strongly regulated by the relevant authorities to assure high quality when administered to patients in clinical trials. Full transparency and traceability, from the origin of the starting materials to dosing and the ultimate destruction of the study medication, all in compliance with Good Manufacturing practices (GMP), is mandatory. Maintaining a GMP-certified status for clean rooms requires continuous investment in equipment, facilities and well-trained people.

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Certifications

• ISO
• EMA (EU GMP)

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Activity

• Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Hard capsules, Terminal sterilization, Fill&Finish, Tubes, Semisolid forms, Terminal sterilization, Fill&Finish, Small volume vials, PFS (Prefilled Syringes), FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), MHRA (UK), TGA (Australia)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Formulation / Galenic design, Process optimization, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage, Distribution, GDP, CMC regulatory support, IMPD (Investigational Medicinal Product Dossier) submission support

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