Astra Logics Inc regulatory strategy is designed to provide enhanced capabilities to advance medical systems towards regulatory approval. The strategy ensures that quality and regulatory integration occurs throughout all stages of development. Our Regulatory Affairs (RA) Team assimilates information from the clinical, non-clinical, manufacturing, and QA functional departments to develop technically-sound regulatory submissions and assure obligations have been fulfilled. The RA Team also reviews technical study designs to ensure that studies meet performance parameters consistent and in accordance with local compliance standards.
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 relevant authorities. The RA Team evaluates published guidance documents to assist in the design of studies to achieve and maintain 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 or information provided to the Sponsor for regulatory interactions. Astra Logic strives to maintain our excellent working relationship with the local regulatory authorities and other subject matter experts so that we ensure that any future regulatory challenges on the pathway to licensure can successfully be addressed.
The primary objectives of our product development plans are to:
• Efficiently manufacture product in accordance with set compliance standards, and; • Develop non-clinical and regulatory strategies to support licensure and provide frequent updates to the appropriate regulatory agencies.
Astra Logics, Inc has provided all relevant documentation to support compliant, successful regulatory interactions that accomplish all the objectives listed above.