Quality management according to GLP & GMP regulation
RD&C offers support for assessment of quality standards according to GLP and GMP in-house or at potential CROs or cooperation partners.
Preparation and execution for audits and inspections
RD&C offers preparation and execution of audits and inspections at potential CROs or cooperation partners.
Quality Systems, handbooks, Standard Operation Procedures (SOP), guidelines
RD&C offers assessment of quality systems, quality of handbooks, SOP, and guidelines, proposals for improvement and optimizations will be included.
Validation of processes (drug substance and drug product in pilot and industrial scale)
RD&C offers validations of manufacturing processes of drug substance and drug products in pilot and industrial scale. An expert report evaluating the quality and applicability of the process based on client’s needs and regulatory requirements will be provided.