Regulatory Approval Expertise
Using our exclusive methodologies for effective resourcing processes, COSERVE Biologics Resourcing Team will use a collaborative methodology, with your team, to assess your product development resourcing plan.
We then identify the appropriate pathway for approval. define all applicable regulatory requirements and craft a customized resource development strategy that minimizes time to clinical trials and regulatory approval.
Our dedicated team will collaborate with your product development team to manage preliminary testing, request, prepare for and attend meetings with the FDA and other key stakeholders, as well as assist in the completion of the IND application for your new product.
Once your IND application has been submitted to the FDA, the Biologics Resourcing Team will support your product development team with advice every step of the way through the IND review process. Our consultants leverage their unique “insider” perspective to interpret Agency requests and communications as well as provide guidance on the latest FDA thinking, thereby positioning your new product for successful outcomes.
Once an IND is allowed to proceed, the clinical stage of development begins. During this stage, the Biologics Resourcing Team supports your clinical trial efforts with quality control and assurance consultants, Clinical Consultants services to customize your product. From designing Phase 1 protocols, to the oversight of clinical trials conducted by contract research organizations, and “FDA-type” review of data generated by Phase 3 studies, our clinical team brings scientific insights, medical and clinical operations knowledge and industry experience necessary to ensure your trials are successful and part of an efficient overall regulatory strategy.
In addition to our expertise in both non-clinical, and clinical quality consulting, and the Biologics Resourcing Team also employs a team of experts in product manufacturing and testing requirements for all classes of pharmaceuticals – knowledge that we leverage to bolster your chances of a successful ANDA or NDA application, regardless of the development pathway. The Biologics Resourcing Team, together with your product team, will ensure that all aspects of testing, manufacturing, storage, and distribution are fully compliant with constantly evolving FDA regulations.
With contributions to more than 75 new BLAs/NDAs (full and supported) submitted, the Biologics Resourcing Team is well positioned to assist your organization in preparing and submitting consultants that assist your marketing application, regardless of pathway.
During the application process, they provide hands-on support, preparation for Agency meetings and guidance in interpreting feedback from CDRH, CDER and CBER. Our team can help translate raw clinical data into a compelling story that will resonate with FDA reviewers, evaluate labeling options and review marketing collateral to ensure accuracy, compliance and the best possible outcome for your product’s application.
Once your product marketing application has been approved and your product is ready to go to market, the Biologics Resourcing Team is able to provide assistance in overseeing manufacturing and quality control, drafting required periodic safety updates for the FDA, and assisting your team throughout the product lifecycle and commercialization processes, including re-positioning the FDA application for international regulatory approvals.
Based on your Product Release Roadmap, the COSERVE specialized team can provide resources that insure your applications are accurate and timely.