fromcomplextoclear

Product Development

Evaluation of clinical development plans, including review of clinical and nonclinical data, FDA correspondence, safety reporting, and sponsor proposals for future clinical studies.

Pathway Evaluation

Determine eligibility for special designation(s), including priority review, fast track, accelerated approval, breakthrough therapy designation, and regenerative medicine advanced therapy designation.

Regulatory Submissions

Review of pending product submissions to assess completeness and approval prospects, including FDA information requests, mid and late-cycle meetings, advisory committee outcomes, labeling negotiations, and inspectional results.

Compliance Status

Analysis of target company’s FDA compliance and enforcement history, including a review of FDA correspondence relating to compliance matters and identification of outstanding or pending compliance and remediation actions.

Distribution & Supply Chain

Assessment of import-export practices, supply chain audit reports, outsourcing arrangements, and distribution procedures.

Preclinical & Clinical Quality Systems

Assessment of compliance with FDA current good laboratory practice (GLP) and good clinical practice (GCP) regulations. 

Reporting Requirements

Confirm that the target company has complied with all requirements for registration, authorization, filing, and listing associated with approved products, including user fee payments and fulfillment of postmarket obligations. 

Quality Manufacturing

Evaluation of the target company’s compliance with FDA quality and manufacturing regulations related to inspections, standard operating procedures, quality assurance activities, and relevant contract manufacturers.

Adverse Event Reporting

Review of adverse event reports (AERs) and good manufacturing practice complaints to ensure that the target company has taken appropriate measures for review and investigation. 

Marketing & Promotion

Evaluation of promotional practices and marketing materials, including labeling claims, promotion of unapproved products or off-label uses, and related FDA correspondence or enforcement actions.