Meetings with regulatory agencies are invaluable in better understanding Agency expectations about the data necessary to support regulatory actions. The questions a sponsor asks, the way in which they are asked, and the discussions around those questions can reduce the data burden and smooth the path to clinical study or product marketing approval or clearance. We have prepared close to 100 meeting requests and packages and prepared clients for effective regulatory agency meetings.
A regulatory strategic plan is critical to defining the overall product development plan and the fastest path to marketing. It considers regulatory agency expectations and precedence for the technical, nonclinical, and clinical data necessary to support a regulatory action. The strategic plan provides timelines and milestones for necessary activities and the implications of delays. As a tracking and planning tool, and a living document, it allows sponsors to manage resources and corporate expectations. Because SciLucent has expertise in all aspects of healthcare product development and testing, we are uniquely suited to provide regulatory strategic support.
Regulatory submissions are packages of information and data needed by a regulatory agency to determine whether a regulated healthcare product may proceed to clinical testing or whether is safe and effective for marketing. We prepare persuasive regulatory submissions that maximize the likelihood of a favorable regulatory agency review, including CMC, nonclinical, and clinical sections of regulatory documents; INDs and NDAs, including amendments and supplements; MAAs; IDEs and PMAs, including amendments and supplements; and 510(k)s.
Most corporate INDs and NDAs are prepared in CTD format and electronically submitted to regulatory agencies. The number and type of regulatory submissions being accepted by FDA in electronic format continues to grow. SciLucent ensures that all regulatory submissions to FDA are published according to relevant guidance and free of technical issues. We establish and manage Electronic Submissions Gateway (ESG) accounts to allow SciLucent to send submissions to FDA on our clients’ behalf.
Not infrequently, regulatory agency review of a submission leads to requests for additional data (technical, nonclinical, or clinical), re-analysis of existing data, or clarification of information. These can hold up clearances to conduct clinical studies or marketing approval clearances or approvals. We have expertise in all aspects of healthcare product development and testing and can work with sponsors to develop responses to regulatory challenges or to implement programs necessary to collect information address data gaps.
Sponsors seek orphan drug designation for their combination of drug and indication because of the many benefits it offers. For some indications, the rarity of the disease or condition is apparent, for others it is an art to identify a patient population that is not artificially created to meet the criteria for orphan designation. We prepare and submit orphan drug designation requests that are scientifically sound and well supported with data.
Expedited review programs can speed up the regulatory agency review process for drugs that meeting certain criteria with regard to the seriousness of the condition they treat, the availability of therapy, and whether treatment is adequately addressed by available therapy. We have prepared and submitted requests for fast track designation, breakthrough designation, accelerated approval, and priority review (shorter review of a marketing application) in several therapeutic areas.
Appropriate packaging is critical for insuring the safety and efficacy of a drug product. Accurate and complete labeling provides the information necessary for healthcare providers and patients to use the products safely and effectively as well as maximizing the value of the product. We assist clients in selecting, testing, qualifying and employing packaging for products being manufactured, dispensed and used around the world.