Regulatory Consulting

Understanding and evaluating the complex regulatory environment for every new product can be an intimidating process. Our regulatory consulting staff, some of whom have served on FDA, EPA, OECD and WHO advisory panels and hail from previous senior-level positions within industry or government, can play a key role on any project by providing you with support during preclinical and clinical development, manufacturing, product licensing and regulatory approvals. Areas of expertise include pharmaceuticals, biologics, medical devices, veterinary medicines and agrochemicals.

Beyond REACH

This webinar replay from SOT 2017 discusses the benefits of taking a global approach when designing a chemical registration program.

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  • Development and registration strategies
  • Data review, gap analysis and strategic advice
  • Documentation and presentation coaching
  • Expert report preparation
  • Clinical trial applications and trial support services
  • Product license variations and defense
  • Product life cycle management
  • Participation on scientific and regulatory advisory boards
  • Scientific and regulatory training on the preclinical aspects of drug development
  • Project management & study monitoring
  • Hazard assessment
  • Classification and labeling (GHS),
  • (Q)SAR, read across, grouping, risk assessment and refinement, Safety Data Sheet
  • Pre-registration consultancy meetings with authorities
  • Consortia management
  • Project coordination
  • Consultancy
Agrochemicals & Biocides
  • Assessment of data requirements
  • Preparation of relevant dossiers
  • Selection of Rapporteur Member State
  • Support for pre-submission meetings and discussions with authorities.
  • Advise on (Q)SAR analysis, read across and/or grouping strategies
  • Import tolerance dossiers
  • Conduct technical equivalence assessments
  • Classification and labeling (CLP/GHS)
  • Preparation of CLH reports

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Non-animal Skin Sensitization Testing Under REACH

This poster shows that a strategic battery of in chemico/in vitro tests, together with an appropriate in silico model, can be combined using a WoE approach to fulfil the requirements for the endpoint skin sensitization for REACH.

Webinar Replay

View our webinar “Keeping Your Biocides on EU Market: Tips and Tricks on BPR Product Registration.”