QUALITY COMPLIANCE SERVICES :
- GxP Auditing
- Quality System Development
- SOP and Documentation Management
- Qualification and Validation Services
- Technical and Scientific Advisory Services (Day to day activities)
- Vendor Registration and Qualification
REGULATORY COMPLIANCE SERVICES :
- Drug Master file (DMF)- Non/Semi Regulated countries/clients
- CEP/COS
- EU DMF
- US DMF
- eCTD Compilation
- DMF-Life cycle management
- Technical Packages
- US Agent Appointment
- DMF review (as per ICH guidance)
INTELLECTUAL PROPERTY RIGHTS :
- Prior art search
- (Patentability/FTO etc.)
- Patents submission
- Trademark
TRAINING AND DEVELOPMENT :
- Introduction to Regulatory Affairs
- ICH guidance
- EMA/EDQM/CEP guidance
- Post approvals changes impacts
- Pharmaceutical Quality systems
- Quality based designed (QBD concept)
- Quality Risk Management
- GMP (Schedule-M)/GLP/GDP
ANALYTICAL DEVELOPMENT & TOXICOLOGICAL EVALUATION :
- Method Validation/Verification
- Absence/carryover/spike studies
- Elemental impurities risk assessment
- Genotoxic Impurities Evaluation
- Structure Elucidation
- HPLC/GC Analysis
API Impurities -
- Azithromycin
- Lornoxicam
- Meloxicam
- Torsemide
- Levetiracetam
- Tranexamic acid
- Fluconazole
- Clopidogrel
- Glimepiride
- Glibenclamide
- Biscodyl
- Sodium picosulphate
- Lidocaine
- Amlodipine Besylate
- Celecoxcib
- Piroxicam
- Rosuvastatin Calcium
