Services
Manufacturing
Custom Chemistry
Custom Chemistry
API, FDF and Intermediate mfg. site
Site with cGMP/WHO GMP/USFDA/EUGMP and PICS compliance
Complete document and Audit support
Custom Chemistry
Custom Chemistry
Custom Chemistry
CDMO/CRO/CRAMs for NCEs
Process Development and optimization
Tech transfers for APIS, FDFs and Intermediates
Regulatory
Custom Chemistry
Regulatory
Global DMF & Dossier filing
GAP analysis and Query response
Documents Translation
Analytical
Regulatory
Analytical Method Development and Transfer
Validation & Verification studies
GTIs/NSA assessment and impurity studies
Market Reach
Product Portfolio Designing
Patent Illustration
Market Reports and Launch Strategy
Compliance and Quality
Audit and compliance
Quality Training and Evaluation
Pre-audit preparations
SAP/ERP implementation