Analysis of your scientific and regulatory targets

Set up of working plans including time lines and cost estimates

Design of specific testing programs

Selection of appropriate Contract Research Organizations

Planning, contracting and monitoring of studies to guarantee full compliance with regulatory requirements and scientific standards for world-wide acceptance

Hazard Evaluation and Risk Assessment within the new EU “REACH” Chemical Law process including data compilation in IUCLID, SIAR, SIAP, SIAM

Medical writing as preparation of Nonclinical Reviews according to the new EU Common Technical Document (CTD) requirements, Safety Expert Reports, Investigator Brochures, IND Sections

Preparation of dossiers for specific scientific endpoints or regulatory purposes as e.g., for cosmetics according the EU SCCNFP requirements or for pesticides within the framework of the Commission Regulation 91/414/EEC

All negotiations between institutes and IRSC prior to placement and contracts

Order of quotations from 2 - 3 CROs

Presentation of quotations

Final selection of CRO

Approval & finalization of protocols

Technical & scientific study monitoring

Consultation of sponsor in case of unexpected results

Approval & finalization of reports

IRSC has detailed knowledge of written laws, regulations and procedures

IRSC has close contact to authorities, scientists from universities, industry and national authorities

IRSC guaranteed a constantly contact to you as client during all phases of support