Independence & governance.
The controls that make GTPR an independent reviewer rather than a regulatory consultancy — screened before every engagement and documented in the regulatory record.
The credibility standard
Independence is not a policy statement. It is a condition of recognition.
Governance framework
The controls that keep GTPR's reviews independent, impartial and confidential.
Regulatory independence
GTPR operates as an independent evaluator. Its review function is organizationally separated from any activity that could compromise impartial assessment.
Conflict of interest
Conflict-of-interest screening is completed before an engagement is accepted. Where a conflict cannot be excluded, GTPR declines the engagement.
Reviewer independence
Reviewers are assigned on the basis of competence and independence from the sponsor and the submission under review.
Quality oversight
Reviews are subject to independent quality review before a determination is finalized.
Confidentiality
Submission information is handled as confidential under controlled access and defined handling procedures.
Impartiality
Determinations are based solely on the technical and regulatory record, applying the same criteria FDA applies.
Sponsor communications
Communications with sponsors occur through the defined review process and are documented in the regulatory record.
FDA communications
GTPR forwards its assessment and recommendation to FDA. Communication with FDA is limited to the review; GTPR does not advocate for the sponsor.
Complaints & appeals
A defined process governs complaints and appeals relating to the conduct of a review.
Record retention
Regulatory records are retained in accordance with applicable requirements.
Data protection
Personal and commercial data are protected under applicable data-protection obligations.
Partnerships & impartiality
Academic and ecosystem partnerships have no influence over eligibility determinations, reviewer assignment, review findings or regulatory recommendations.
Controlled governance documents — including the Conflict of Interest, Reviewer Independence, Confidentiality, Complaints & Appeals, Quality policies and Code of Conduct — are maintained under version control and are available to sponsors on request as part of an engagement.
Review our position on independence and conflicts.
Governance underpins every GTPR engagement.