- Technology Development Centre in India with focus on new APIs with non-infringing process development.
- Technology transfer from Lab to Plant.
- Highly qualified team for Process and Analytical Development,Experienced Regulatory and IPR Team.
- Emphasis on QMS complying to ICH Q7A - GMP guidelines, 21 CFR Part 210-211 and WHO GMP.
Over the years we have partnered with some of the best names in the International Pharma Industry to provide our customers with consistent and customized service :-
Core Effective Process
Our Capabilities for services in API & Formulation Business
- Cost Effective Process Development & Manufacturing - APIs & Intermediates.
- Documentation for Technology Transfer (TT).
- Quality Assurance System establishment in organization & providing services for QA along with Regulatory Filings (DMFs / ANDA).
- Contract Research Projects.
CRAMS Product Development in case of APIs and Formulations are done in the below sequence of operations:-
- Selection of molecule (information from client) followed by Literature Survey.
- Selection of ROS followed by Technical and then Commercial Proposal.
- Preparation of Protocol and approval from client.
- Development of the product as per timelines meeting technical specifications.
Analytical method development and analysis.
- Compatibility Studies to be done (in case of formulations).
- Stability Program Management and Analytical Method Validation.
- Product Development Report and Product Transfer.