Validation & compliance consulting
Inspection-ready facilities, systems and quality programs
Client Focused. Quality Driven.
We help 503A pharmacies, 503B outsourcing facilities, medical device manufacturers, biologics developers and CDMOs start up, validate and stay compliant. Our consultants have run quality, production and facilities themselves, and have hosted FDA inspections.
Industries
Specialists in the places regulators look hardest
Each sector has its own rules, its own inspection habits and its own failure points. We staff every project with people who have worked inside that kind of facility.
503A & 503B Compounding
Cleanroom qualification, USP <797> and <800> programs, and cGMP quality systems for outsourcing facilities. Start-up, 503A to 503B transition, and FDA 483 remediation.
Medical Devices
QMSR and ISO 13485 quality systems, design controls, risk management, and process, sterilization and packaging validation.
Biologics & Cell Therapy
Aseptic suite CQV, cold chain and controlled-temperature storage qualification, and quality systems under 21 CFR 600 and 1271.
CDMOs & Sponsors
Technology transfer, multi-product cleaning validation, client-audit readiness, and sponsor oversight of contract manufacturers.
Services
One partner from design review to inspection day
Validation & CQV
Validation Master Plans, commissioning, IQ/OQ/PQ, process and cleaning validation, temperature mapping, and computer system validation under Part 11.
Quality & Compliance
GxP audits, mock FDA inspections, QMS design, investigations and CAPA, 483 and Warning Letter response, training, and interim quality leadership.
How a validation project runs
From design drawings to final report
Validation is cheapest when it starts at conceptual design. We review drawings early, work alongside your contractors during construction, and lay the validation schedule over the installation schedule.
Validation Master Plan
Scope, strategy and acceptance approach, written during design.
Commissioning
Contractor testing captured so it can support IQ without repeating it.
Installation Qualification
Drafted as drawings, specs and vendor submittals arrive.
Operational Qualification
Written once equipment manuals and SOPs are in place.
Performance Qualification
Process, cleaning and aseptic process simulation.
Final Report
Deviations investigated and closed before any retest.
Why clients choose us
Practitioners, not career consultants
- We have done your job. Most of our project leads have served as QA, production or facility managers, including at FDA-registered 503B outsourcing facilities.
- Practical, defensible protocols. Concise documents with clear acceptance criteria that hold up in an inspection.
- One accountable project manager with a weekly progress report, updated timeline and budget.
- Transparent fees. Every activity is itemized with its hours, and reimbursable expenses carry no mark-up.
- Senior attention on every project, whatever its size.
Our mission
To be a global leader in validation and compliance services for the pharmaceutical, biotechnology, biologics and medical device industries.
Our team includes PharmDs, chemists, microbiologists, engineers and computer scientists.
Partner with us
Ready to talk about your project?
Send us your scope, drawings or audit findings and we will come back with a clear, itemized proposal.