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Regulatory Support
Regulatory submissions and labeling support for pharmaceutical, biopharmaceutical, and medical device companies
Quality Confidential is a women-owned GxP consulting firm that helps pharmaceutical, biopharmaceutical, and medical device companies move regulatory submissions forward and get labeling right the first time.
Our rigorously vetted global network of 200+ senior to executive-level QA, QC, and RA consultants has completed submission projects of every size, from artwork and inserts to CMC review, application completion, and electronic submission, for companies from start-ups to Fortune 500.
Regulatory Support Services
Submission Preparation and Review
Support at every phase of product development, from copy review for artwork and inserts to full application review, building a clear roadmap to submission completion.
CMC Review and Application Completion
Experienced review of chemistry, manufacturing, and controls content and completion of applications, so your submission is accurate, complete, and on time.
Electronic Submissions
Preparation and electronic submission support that helps reduce the time it takes to complete regulatory submissions.
Global Labeling and UDI Requirements
Guidance on global labeling and unique device identification, including UDI implementation experience gained with large, global medical device companies.
New laws worldwide require unique identifiers in drug and device packaging to counter counterfeiting. For medical devices, the FDA's unique device identification system means the label of most devices will carry a UDI in human-readable and machine-readable form. Our consultants have implemented UDI requirements for large, global medical device companies.
Faster, Cleaner Submissions
Consultants who have completed submission projects of every size, from small to global
Electronic submission experience that helps reduce time to completion
A clear roadmap to submission completion, tailored to your product and phase
UDI implementation delivered for large, global medical device companies
Consultant Qualifications
Consultants are matched to each engagement based on education, certification, industry experience, knowledge of applicable regulations, and the specific needs of your project. Levels range from Senior Compliance Consultants to Principal Consultants and former regulatory authority investigators.
Former FDA and regulatory authority investigators
ASQ CQA and ISO Standard certified professionals
Specialized subject matter experts across GxP disciplines
Former senior industry executives
Women-Owned Business
Quality Confidential consultants bring decades of industry and FDA-facing pharmaceutical and biopharmaceutical experience. The Quality Confidential consultant network reflects the diversity of the global life sciences industry, with professionals spanning pharma, biotech, gene therapy, medical devices, IVD, and diagnostics across multiple countries.
Why Quality Confidential
Confidential by design
No client logos, no case studies. Every engagement is a protected relationship.
Senior-level expertise
Every engagement is led by senior professionals with decades of real-world industry and regulatory experience.
Integrity above profit
We recommend only what serves patients and your long-term compliance.
Practical and sustainable
Recommendations and deliverables built to hold up in real operations, not just on paper.
Have a submission or labeling project on the horizon?
Tell us where you are in the process and we will match you with a consultant who has done it before, in complete confidence.
Request a Confidential Consultationinfo@qualityconfidential.com | 919-622-5826