Generic formulation development, manufacturing and marketing
We have a cGMP compliant R&D facility for formulation manufacturing, testing and development. We also have the capability to develop formulations along with requisite BA/BE studies, regulatory services and filing of the ANDAs. We also contract manufacture the developed formulations for US and ROW markets. Our present reach of marketing formulations expands across Singapore, Malaysia and South Africa and various other countries through partnerships.
APIS, CRAMS and Advanced Intermediates Development and Marketing
With extensive knowledge of pharmaceutical ingredients over the past years we can say with confidence that we along with our partners have the ability to develop complex chemistry.
We along with our partners have worked with almost all MNCs, developing CRAMs and intermediates with complicated technology.
We have partnerships with multiple R&D Centre with state of the art instruments for carrying out complex chemistry. With our partners, we have efficiently handled the development of products in a confidential and exclusive basis.
Clinical studies and Clinical data management
Our CRO business has gained primary importance in the services that we provide. Along with our partners have implemented Oracle Clinical, enabling improved operational efficiency and productivity even in complex trial design scenarios. Our top priority is to maintain consistent data quality that includes functionality across multiple areas: Trial Budgeting, Regulatory Affairs, Data Management, Pharmacovigilance in collaboration with our associates, Medical Writing, Clinical Operations and Statistical Analysis.
We have the expertise to provide expert clinical and regulatory support through all phases of global drug development to commercialization, from BA/BE Analysis to Quality cGMP compliance. We prepare all regulatory documentation including filing of DMFs, ANDAs and maintaining post approval change management. Our proficiency in organising quality dossiers ensures timely approvals. We have the bandwidth to support the clinic and regulatory activities across the USA, EU, Asia Pacific and Latin America.