919016575294 919016575294
VS Chemipharma

Impurity and Services

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




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