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Outsourcing Pharmaceutical Center
Main Operation Areas:
1. Pharmaceutical development:
- Formulation/Reformulation work;
- Compatibility studies (DSC/TGA/IR/UV/NMR/MS);
- Preservative efficacy;
- Comparative in-vitro studies of generic and reference products - Dissolution/Impurity profiles.
2. Quality control:
- Analyses of drug substances and dosage forms;
- Batch certificates;
- Analytical method development, validation and inter-laboratory transfer;
- Stability testing (long-term, accelerated and stress);
- Microbiological tests;
3. Consultancy service in chromatography
- HPLC, HPLC – MS, HPLC - MS/MS;
- GC and GC/MS;
- Express consulting and technical support to your chromatography needs.
4. Quality assurance:
- Analytical procedures, reports and SOP’s;
- GMP consult and validation documents.
5. Regulatory affairs:
- Completely review and assessment of the dossier;
- Marketing researches and recommendations;
- Prepare/Update the chemical and pharmaceutical parts of the dossier (CTD);
- Expert reports;
- Regulatory work – procedures, consult and support.
- Main resources:
1. General lab equipment (chemical and microbiological);
2. Instrumental analytical equipment;
3. Stability chambers;
4. Technical Databases.
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