Regulatory Affairs

We are experienced in the interpretation of applicable FDA and EMA regulations to ensure compliance, and we support efficient navigation through the multidimensional regulatory landscape.

Support for regulatory strategy and development planning, regulatory submissions and agency questions, cGxP compliance, and pre-approval inspection (PAI) readiness.

We emphasize a patient-centric, risk-based approach that supports the introduction and ongoing support of a variety of products including first-in-class products and their unique challenges.

We can perform a regulatory pathway analysis for drugs, devices, biologics, or combination products. We can identify relevant guidances or requirements relevant to the product, assess the appropriate approval pathway. We perform these assessments for the US or other countries as requested and author our findings in a presentation or report.

We have helped many clients with their Orphan Drug Designation (ODD) requests. First, we conduct an assessment of disease prevalence and existing ODD indications for an Active Pharmaceutical Ingredient (API) to confirm eligibility. We then prepare the ODD request per FDA requirements and submit if requested.

Kymanox can author or review your FDA expedited program request including Fast Track Requests (FTRs), Breakthrough Therapy Requests (BTRs), Accelerated Approval (AA) assessments or requests, and Priority Review (PR) assessment or requests. We will ensure these documents follow FDA guidelines and applicable standards.

Our regulatory experts have experience performing gap assessments of our clients' clinical strategies or clinical endpoints including the overall clinical program, synopsis of a clinical study, or identification of primary endpoints. We can also perform a gap assessment of the eCTD sections of your New Dug Application (NDA) or Biologic License Application (BLA) and identify potential regulatory risks and level of risk with respect to Refuse to File (RTF) or potential for approval. We can also perform a regulatory assessment of the device class, product code, predicate assessment (if applicable) to determine the appropriate pathway for commercialization in the US or other countries as specified; identify any special controls or relevant guidance. Our team can also help assess and identify new indications for existing drugs or new dosage forms/route of administration.

Our regulatory team has experience authoring initial Pediatric Study Plans (iPSPs) and addressing FDA comments to a "non-agreement" iPSP. We can also participate in FDA meetings to negotiate requirements as applicable.