Contract development and manufacturing organizations face compounded complexity: maintaining multiple client quality systems within shared validated infrastructure. We support the professionals and programs that keep those environments compliant.
Quality and compliance support across programs for diverse pharmaceutical and biotech customers.
Understanding the validation implications of shared systems serving multiple clients.
Operating within the quality agreements you hold with each client.
Validation support as products and processes move between sites and organizations.
A growing CDMO adding pharmaceutical clients needs a contract Quality Systems Manager with multi-client GMP experience and validated systems knowledge to build out compliance infrastructure across programs.
A biotech preparing for its first FDA pre-approval inspection needs contract compliance and CSV support, including mock inspections, documentation review, and validated systems and electronic records that meet Part 11 and Annex 11 requirements before the inspection window.
A compliance and audit specialist supports a supplier audit program, planning and conducting audits and driving findings to closure.
Tell us about your organization, regulatory environment, and need. We will scope the engagement against your specific GxP context.