RD&C is an expert office providing specific in-depth expertise for your pharmaceutical or biotech project

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IMPURITIES

  • Expert statements on impurities
  • Impurity and degradation profiling
  • Evaluation of degradation pathways
  • Expertise in solid state degradation
  • Management of oos events
  • Route cause analysis, CAPAs, etc.
  • in silico mutagenicity assessments
  • Stability by Design

REGULATORY

  • Regulatory advice for CMC
  • Expert statements on CMC
  • Chinese DMFs (one-stop-shop)
  • Scientific advices (FDA, EMA)
  • DMF, IMPD, CTD module 3
  • Risk Assessment Element. Imurities
  • Risk Assessment Nitrosamines
  • FDA compliance of documentation
  • Combination products
  • Environmental Risk Assessment
  • Due Diligences
  • GMP Audit

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CONCEPTS

  • IP strategies
  • Drug discovery
  • Drug development
  • Project management
  • CRO/CMO identification
  • In-depth market knowledge
  • Innovative scientific concepts

News

  • DR. Helmut Buschmann published with Prof. Ulrike Holzgrabe in DAZ

    Deutsche Apotheke Zeitung | 159. Jahrgang | 10.01.2019 | Nr. 1/2

    - RD&C Team
  • Risk Assessment Nitrosamine

    EMA and edqm ask MAH to evaluate the risk of nitrosamines in marketed synthetic drugs. Risk assessment has to be conducted for drug substance, excipients and drug product. RD&C will assist clients.

    - RD&C Team
  • Prof. Holzgrabe and Dr. Buschmann published in DAZ

    Prof. Ulrike Holzgrabe (University Wuerzburg) and Helmut Buschmann (RD&C) published a recent article in DAZ on Remifentanil

    - Dr. Helmut Buschmann
  • RD&C as invited speakers for 2-days-workshop “Stability by Design”

    Concept Heidelberg/ECA invited Helmut Buschmann and Norbert Handler to give talks for the workshop "Stability by Design". The 2-day course will be held in Hamburg on April 19th to 20th 2018.

    - RD&C team
  • SOLID STATE REACTION PLATFORM

    The method could be used for prediction of stability, polymorph changes, shelf-life, degradations in solid environment as well as development tool for solid formulations. The service is offered to customers, but is also open for out-licensing.

    - RD&C Team
  • RD&C GmbH registered the Austrian trade „CONSULTING ENGINEER FOR PHARMACY (Ingenieurbüro für Pharmazie)”.

    The strictly regulated trade "Consulting Engineer" warrants a broad technical expert background with an objective view, directed towards protecting the clients’ interests and ensuring superior performance at the lowest commensurate cost. It includes an expert status in the field ensuring quality, employability and professional recognition.

    - Dr. Norbert Handler
  • Dr. Norbert HANDLER is announced “general authorized and certified expert for pharamceutical chemistry” at the Trade Court of Vienna

    The expert status is announced for 5 years comprises the fields pharmaceutical chemistry, pharmaceutical products and cosmetics.

    - RD&C team
  • DMF Applications in China

    RD&C can act as one-stop-shop for your DMF-application at NMPA in China (including translation, contact to authorities, registration account, regulatory support). Please contact us for more information.

    - RD&C team