
This is another boutique service by ComplyWell Solutions. We will work as a member of your team and lead the QA strategy and items during product development. Our in-depth experience in R&D QA and regulatory affairs can help you navigate the GLP, GCP and GMP compliance dilemma through the product development (new and generic) and scale-up and develop the culture of sustainable compliance.
Be it the selection and audit of your GXP vendors, review of the operational and quality agreements, on-going compliance or management of the regulatory inspections, ComplyWell Solutions will monitor the GXP compliance of the entire spectrum of activities on your development program (e.g. biosimilar development) and will guide you to remain inspection-ready.