REGULATORY

Environmental Risk Assessment

RD&C has a sound track record in preparing ERAs with experience in various types of formulations (oral, parenteral, inhalation, transdermal etc.). We have successfully provided ERAs for different drug classes such as hormones, endocrine disruptors, NCE, generics, antibiotics, etc. at most efficient resource investment.

  • Calculation of Fpen and PEC values: Fpen refinement based on prevalence data and evaluation of suitability of market data
  • Consideration and interpretation of literature data
  • Full in silico environmental risk assessment
  • Appraisal of physicochemical parameters on environmental fate
  • Chemical evaluation of degradation pathways and drug metabolism; evaluation of relevance for ERA
  • Environmental fate and purge discussions
  • Strong efforts to keep laboratory experiments to a minimum
  • Selection of most relevant assays, species and experimental set-up
  • Selection and close interaction with CROs
  • Discussion with authorities
  • Compilation of comprehensive regulatory compliant ERA documents

 

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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).

 

Biowaiver assessment

RD&C offers biowaiver assessments using in-house and public assessment data to justify waiver of in vivo bioavailability and bioequivalence studies.