Key Activity
Clinical Research
- Clinical Trials (phase I to IV)
- Clinical Trial Design
- Clinical Data Management
- Biostatistics
- Clinical Supplies
- Bioavailability Studies
- Bioequivalence Studies
- Preclinical Studies
- Toxicological Studies
- Periodic Safety Update Report (PSUR)
Analytical Research
- Analytical Method Validations
- Analytical Method Development
- Dissolution Profile
- Stability Data Studies
- Analytical Report
- Bioanalytical Services
- Product Performance Testing
- Related Substances Report
- Quantitative Analysis
- Physical Analysis
Regulatory Dossiers & Documentation
- Dossier Preparation & Reformation (EU-CTD, CTD, ACTD formats)
- Dossier Compilation & Reformation in CTD format for Russia, CIS, Central & South America, Middle East, Africa, Asia, UK-MHRA, TGA-Australia, MCC-South Africa, Medsafe-New Zealand, ANVISA-Brazil
- Submission Preparation & Compilation for INDs, NDAs, ANDA, BLAs, INADs, NADAs
- e-CTD preparation and conversion
Process Research
- Process Validation
- Formulation & Development
- Novel Drug Delivery System (NDDS)