rdc-concepts.com

RD&C Concepts GmbH | Research, Development & Consulting

A novel integrated analysis tool. Deviation management & OOS. In drug development and routine manufacturing. In pharmaceutical drug process development. Scientific and strategic solutions. Innovative approaches on exciting targets. RD&C developed a novel systemic analysis concept for impurity profiling in pharmaceutical drug process development and impurity related deviation management at development stage or in routine drug manufacturing. RD&C together with ICIQ. Meet RD&C at the CPhI in Madrid! This ac...

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RD&C Impurity GmbH

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RD&C Concepts GmbH | Research, Development & Consulting | rdc-concepts.com Reviews

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A novel integrated analysis tool. Deviation management & OOS. In drug development and routine manufacturing. In pharmaceutical drug process development. Scientific and strategic solutions. Innovative approaches on exciting targets. RD&C developed a novel systemic analysis concept for impurity profiling in pharmaceutical drug process development and impurity related deviation management at development stage or in routine drug manufacturing. RD&C together with ICIQ. Meet RD&C at the CPhI in Madrid! This ac...

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9 regulatory support

10 drug development

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RD&C Concepts GmbH | Research, Development & Consulting | rdc-concepts.com Reviews

https://rdc-concepts.com

A novel integrated analysis tool. Deviation management & OOS. In drug development and routine manufacturing. In pharmaceutical drug process development. Scientific and strategic solutions. Innovative approaches on exciting targets. RD&C developed a novel systemic analysis concept for impurity profiling in pharmaceutical drug process development and impurity related deviation management at development stage or in routine drug manufacturing. RD&C together with ICIQ. Meet RD&C at the CPhI in Madrid! This ac...

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rdc-concepts.com

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RD&C Concepts GmbH | Pharmaceutical impurities and degradation products

http://rdc-concepts.com/impurity

System impurity analysis concept. Solid phase reaction toolbox. PHARMACEUTICAL IMPURITIES AND DEGRADATION PRODUCTS. The impurity profile is a crucial factor for the quality of drugs and processes. Deficiencies on impurity profiles are among the top ten reasons for revenue losses through delayed product launch, decreased shelf life, etc. 8211; high development costs. Short product shelf life. 8211; competitive disadvantage. RD&C Research, Development and Consulting GmbH. 1170 Vienna - Austria.

2

RD&C Concepts GmbH | Strategy development and proposal of an regulatory compliant argumentation line for critical pharmaceutical development processes.

http://rdc-concepts.com/portfolio/regulatory-support

Impurities and degradation products. Environmental Risk Assessment (ERA). In silico toxicology assessment. Commercial evaluation of drug development projects. Evaluation of production processes. Support for CRO selection. Statistics in drug development. RD&C’s recent publications and scientific talks. Strategy and proposal of regulatory compliant argumentation. Chemistry, Manufacturing and Controls (CMC). Preparation of Quality Overall Summary (QOS). Environmental Risk Assessments (ERA). Toxicologic asse...

3

RD&C Concepts GmbH | A holistic analysis of the entire production process to solve impurity issues

http://rdc-concepts.com/page-elements/subpage

System impurity analysis concept. System impurity analysis concept. Solid phase reaction toolbox. A HOLISTIC ANALYSIS OF THE ENTIRE PRODUCTION PROCESS. 1 Analysis of each reaction step in the synthesis pathway of the drug substance. Raw material, reaction intermediates, by-products, reactants. 2 Structure based analogy analysis. Evaluation of monographed drug substance impurities of certain members of a drug class allows analogy conclusions for other members of the same drug family. 5 Packaging induced r...

4

RD&C Concepts GmbH | Synergistic efficacy and improved bioavailability through pharmaceutical co-crystals.

http://rdc-concepts.com/synergy

Develops novel co-crystals and crystalline multi-component structures formed by two or more molecules to generate synergistic efficacy based on improved bioavailability, increased solubility, or decreased plasma protein binding of current treatment options pursuing the concept of polypharmacology, the treatment of diseases by modulating more than one target. RD&C Research, Development and Consulting GmbH. 1170 Vienna - Austria. Phone: 43 1 23672897408. Währinger Strasse 61/2.03a. 1090 Vienna - Austria.

5

RD&C Concepts GmbH | Innovative pharmaceutical development concepts/ projects at reduced risk

http://rdc-concepts.com/concepts

RD&C BRINGS HIGH QUALITY AND CUSTOMISED EXPERTISE TO THE LIFE SCIENCE COMMUNITY. RD&C combines in depth scientific knowledge of various research disciplines to coordinate and guide innovative concepts for new drug candidates. Regulatory compliant drug development documentation and expert dossiers are provided on sound scientific and regulatory experience. Co-crystals of sartanes for improved bioavailability and efficacy. Co-crystals of statins for improved bioavailability and efficacy. Co-crystals for im...

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RD&C Concepts GmbH | Research, Development & Consulting

A novel integrated analysis tool. Deviation management & OOS. In drug development and routine manufacturing. In pharmaceutical drug process development. Scientific and strategic solutions. Innovative approaches on exciting targets. RD&C developed a novel systemic analysis concept for impurity profiling in pharmaceutical drug process development and impurity related deviation management at development stage or in routine drug manufacturing. RD&C together with ICIQ. Meet RD&C at the CPhI in Madrid! This ac...

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