Strategy and proposal of regulatory compliant argumentation
RD&C assists its clients in designing strategies for regulatory compliant argumentation at various issues focussing on most time- and cost-efficient solutions. Available data will be evaluated and proposals with additional activities and experiments for strengthening and optimizing argumentation lines will be prepared.
Chemistry, Manufacturing and Controls (CMC)
RD&C analyzes and evaluates CMC documentation elucidating shortages and quality deficits to accelerate and optimize the regulatory process.
Preparation of Quality Overall Summary (QOS)
RD&C is proud to offer Quality Overall Summaries (QOS) to its clients due to its sucessful experience as authority approved experts.
Environmental Risk Assessments (ERA)
RD&C generates Environmental Risk Assessments (ERA) for regulatory submissions in a time- and cost-efficient manner. Our approach includes extensive literature search, evaluation of calculated and measured data, in silico toxicologic assessment of drug molecules and metabolites, and an optional plan for useful ecotoxicologic tests. RD&C’s main ambition is to provide its clients efficient and cost saving argumentation lines considering drug product properties, target indication, and market situation.
Common Technical Document (CTD) – impurities and specification
RD&C offers support in writing of modules 2 and 3 of the CTD in general. Additionally, argumentation and justification strategies for chapters dealing with impurities, degradation products, and stability tests can be elaborated and optimized for a rapid and safe registration procedure.
Compilation of expert reports
RD&C offers compilation of (a.u.) Investigator Brochure (IB), Investigational New Drug (IND) Application and Investigational Medicinal Product Dossiers (IMPD).
RD&C offers biowaiver assessments using in-house and public assessment data to justify waiver of in vivo bioavailability and bioequivalence studies.