To best cater the complexities of the pharma production procedures and to have a stable formulation, our efficient Technical Sales Team helps our clients in choosing the correct source of raw materials, having the desired technical specifications.
- 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:-
1. ACTIVE PHARMACEUTICAL INGREDIENTS - APIs
- 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
- 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 & Analytical Method Validation.
- Product Development Report (TT) and Product Transfer.
Our Capabilities for services in API & Formulation Business:-
CRAMS Product Development in case of APIs and Formulations are done in the below sequence of operations:-