Regulatory Affairs

Meetings with regulatory agencies are invaluable to better understand Agency expectations about 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 product development, nonclinical and clinical testing, and marketing approval or clearance. We prepare meeting requests and packages to help clients succeed in effective regulatory agency interactions from early phase development through the filing of the marketing application. We also serve as a regulatory correspondent or U.S. Agent on behalf of our sponsors to assist in the effective communication with regulatory agencies.

A regulatory strategic plan is critical to defining the overall product development plan and the fastest path to clinical testing and marketing. The plan considers regulatory agency expectations and precedence for the nonclinical, CMC, and clinical data necessary to support a regulatory action. It provides timelines and milestones for necessary activities and the implications of delays. As a living document for planning and tracking projects, 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 contain critical nonclinical, CMC, and clinical information needed by a regulatory agency to determine whether a regulated healthcare product may proceed to clinical testing or whether it is safe and effective for marketing. We prepare persuasive strategic regulatory submissions that maximize the probability of regulatory success, including: INDs, CTAs, IMPDs, NDAs, BLAs, NDSs, MAAs, DMFs, and any related amendments and supplements.

Not infrequently, regulatory agency review of a submission leads to requests for additional data (nonclinical, CMC or clinical), re-analysis of existing data, or clarification of information. These can hold up clearances to conduct clinical studies or marketing approvals. We have expertise in all aspects of healthcare product development and testing and work with sponsors to develop responses to regulatory challenges or to implement programs necessary to collect information to address data gaps.

Sponsors may seek orphan drug designation for their investigational products for the treatment of rare diseases because of the many benefits orphan designation offers. For some indications, the rarity of the disease or condition is readily apparent; however, for others it can be very challenging to identify and/or justify a patient population that meets the criteria for orphan designation. We prepare and submit orphan drug designation requests that are scientifically sound and well supported with scientific data.

Expedited review programs can speed up the regulatory agency review process for drugs that meet 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 prepare and submit requests for fast track designation, breakthrough designation, accelerated approval, and priority review in several therapeutic areas.

SciLucent’s support for regulated products doesn’t end at the time of marketing approval. Working with SPL vendors, we manage activities such as labeling updates, drug registration, establishment listings, and lot distribution reports. Postapproval pharmacovigilance is a major component of regulatory requirements for marketed products. We provide postmarketing safety reporting services as well as preparation and submission of Periodic Safety Update Reports or Periodic Benefit-Risk Evaluation Reports. We review promotional material for compliance with regulations for not only product name placement, size, and prominence, but also for content, to ensure that the information contained in these promotional materials is not false or misleading.