We take up extensive process research and development right from route selection, process research using QbD approaches and ICH Q11, gentoxic evaluations as per ICH M7, control strategy, Product development reports, process safety evaluations, scale-up/ pilot plant trials, analytical method validations. Technology transfer to the GMP locations, Process validations, DMF filings, regulatory responses and commercial manufacturing.
We provide the services & Strategic partnership for development, Validations, DMF filing and commercial manufacturing of APIs and Intermediates of APIs. We are flexible in our business model to support various clients.
A). After Product development, technology transfer to Contract Manufacturing GMP plants, executing the Process validation batches, DMF filing followed by manufacturing upon commercialization and life cycle management of the products.
B). Alternatively technology transfer to client GMP locations as per the client requirement and executing the Process validation batches, DMF filing, followed by manufacturing upon commercialization and life cycle management of the products.