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CRO/CDMO Services for APIs
Our Strengths in CRO/CDMO Services
Strong R&D Capabilities
Design of robust multi-step industrial processes from Lab Scale
Telescoping to reduce number of stages and improve Green Chemistry and Engineering
Evaluating criticality, critical stages to be converted to flow mode to improve process safety
Reduced risk and cost of industrial implementation through integration of R&D and industrial teams
cGMP Evaluated Workspace and Pilot Plant
Regulatory Management on APIs and KSMs
Strong QC & QA management
Regulatory documents filing
Continuous process for improving VTO, Green Chemistry and Engineering points
Energy balancing to achieve ultimate engineering excellence
VIRUJ - Your Strategic Partner in CDMO
CRO / CDMO Services – Flow & Conventional Method
Development of Generic APIs (New and Old) – Exclusive or Semi Exclusive with IP Management
Tech Advancement for Complex APIs
Custom Synthesis
Complex API’s – Tech advancement
Custom Synthesis
Transfer of Technology for Commercial APIs / KSM’s
Business Prospects through our existing list of APIs / Fine Chemicals
From Early Clinical Phase To Right Up To Commercial Manufacturing
PRE-CLINICAL
Synthesis route design, scouting, telescoping, batch to flow conversion, Process engineering and process safety
Analytical development
Representative sample synthesis
Industrial cost evaluation
Industrial raw material sourcing and supply chain management
CLINICAL
Chemical process development and optimization, telescoping, batch to flow conversion
Key process parameters study
Quality by design methodologies
GMP clinical batches production
IMP dossier preparation
Validation of analytical methods
COMMERCIAL
Manufacturing process validation, with a stipulated time period, improved VTO and Green Chemistry engineering process
ASMF preparation and filing
Quality and Regulatory support
Industrial scale cGMP production
Continuous improvement
API lifecycle management
