Gaining regulatory approval for a new product is a significant, however this may only be the beginning. Developing data to support new claims, new patients or more efficient manufacturing steps require update and modification to the regulatory status and documentation. Accelagen can provide expert support in the strategic management of the regulatory processes, including preparation and lodgment of new submissions, preparation of responses to Agency questions and documenting any post-approval commitments agreed with the Agency. We can critically evaluate new data intended to support a variation and determine if any additional data or information may required. Our staff can also advise on possible study designs/outcomes that we would consider necessary to be part of the submission.
Whether your requirements are large or small, get in touch with us to see how we can benefit your company.