Pharmaceutical Services
Clinical IMP Manufacturing
Our state-of-the-art cGMP production facility specialized in the manufacturing of pivotal batches for clinical trial across various dosage forms, including solid (tablets, capsules and powders), semi-solid, and non-sterile liquid presentations in well suited/ appropriateprimary packaging (blisters, bottles and sachets). The plant supports clinical development phases.
Clinical Supply
Located within our cutting-edge cGMP production plant, the Clinical Supply Unit provides end-to-end clinical supply chain solutions.
Our expertise extends to consultancy, Qualified Person (QP) EU batch release, and guidance for best practice for clinical trials in full compliance with current EU regulations.
Comprehensive Services include:
- Comparator Drug Identification
- De-blistering
- Blinding Services
- Primary Packaging (blisters, bottles and sachets)
- Patient Kit design development
- Label Text proposal
- Reference/Retention samples
- Product Specification File
- Investigational Medicinal Product Dossier (IMPD)
- Randomization
- Patient Kit Preparation/QP Batch Release
- Clinical Study Material Management including Auxiliary Medicinal Products (AMPs)
- Shipment management
- Quality Technical Agreements (QTAs)
- Returns management.
GxP Services
(Good Manufacturing Practices – GMP; Good Distribution Practices – GDP, Good Clinical Practices – GCP; Good Laboratory Practices – GLP).
- Analytical Development, Validation and Transfer
- Quality Control Testing
- ICH Stability Studies
- EU Quality Control Testing & QP Batch Release according to Annex 16 – GMP
Quality by Design (QbD)
- Formulation & Process Development according to ICH Q8
- Analytical Development & Validation according to ICH Q14 & ICHQ2R2
R&D Activities
Advanced Solid State Characterization supporting formulation development, process optimization and regulatory compliance.
- Particle Size Distribution (LLS)
- Microscopy & Image Analysis
- Density Measurements
- Specific Surface Area & Pore Analysis (BET)
- Thermal Analysis (DSC/TGA)
- Spectroscopy (FTIR and Raman)
Analytical Services:
- Forced degradation studies
- Analytical method development and Validation
- Structural identification and characterization of impurities
- Dissolution & Solubility studies
- ICH stability testing
- General Chromatography (UPLC, HPLC/UV, HPLC/MS and GC)
Drug Substance (DS) and Drug Product (DP) Formulation Studies:
- Physico-Chemical Properties Evaluation
- Drug-Excipient Compatibility
- Solid Dosage Form Development
- Solution/Suspension Formulation
- Topical Formulation Development (creams, gels, and ointments)
- Nano-Suspension Development to enhance solubility and bioavailability for DS Biopharmaceutical Classification System (BCS) class III and IV.
- Amorphous Solid Dispersions