The regulatory strategy we provide is designed to enhance capabilities and advance medical products towards regulatory approval. The strategy ensures that quality and regulatory integration occurs throughout all stages of development. The Regulatory Affairs (RA) Team assimilates information from the clinical, nonclinical, manufacturing, and QA functional departments to develop technically-sound FDA submissions and assure regulatory obligations have been fulfilled. The RA Team reviews technical study designs to ensure that studies meet performance parameters consistent with client requirements and in accordance with FDA compliance standards.
Well written documents and organized, readily accessible documentation systems support successful regulatory interactions to accomplish the objectives listed above.
The RA Team develops strategies using a proven model that has successfully moved products through clinical development and subsequent licensure. The model engages experts from all functional areas on a continuing basis so that real-time strategic and technical adjustments can be made and clearly communicated to the FDA. The RA Team evaluates published guidance documents from the FDA, International Conference on Harmonization (ICH), European Medicines Agency, and Health Canada to assist in the design of studies to achieve and maintain FDA licensure and to support international regulatory activities by government stakeholders. The RA Team has experience with product development and marketing application approval as a product sponsor and in supporting the product sponsor.
The RA Team maintains an Overall Product History (OPH) for each product that documents all forms of communication with the FDA or information provided to the Sponsor for FDA interactions. Ology Bio strives to maintain our excellent working relationship with the FDA and other subject matter experts so that we ensure that any future regulatory challenges on the pathway to licensure can be successfully addressed. The primary objectives of our product development plans are to:
- Effectively technology transfer a product into the manufacturing facility
- Efficiently manufacture product in accordance with cGMP
- Develop Chemistry, Manufacturing, and Controls (CMC), nonclinical and regulatory strategies to support licensure and present and provide frequent updates to the appropriate regulatory agency
- Successfully perform pivotal studies to support licensure
- Support a label indication for the product that meets DoD and sponsor objectives and FDA requirements for licensure