PROJECT MANAGEMENT AND REGULATORY AFFAIRS
CIT offers a complete set of services in project management and regulatory affairs, based on a unique combination of resources, expertise and information.

The Regulatory Affairs Department at CIT can offer assistance in:

• Information
• Strategy
• Global cost evaluation
• Resources and outsourcing
• Contact with authorities and follow-up

PROJECT MANAGEMENT

We have a dedicated team of well experiences persons who are in charge of project management. The management can include all steps of the projects or specific issues. Possible Services include:

• Pre-evaluation of your project in order to set up the best (and most cost effective) set of studies. This can include discussion with the authorities, if necessary,
• Project coordination: the project manager will prepare with you an agreed time frame for project and the structure of the follow-up (format, content, frequency).

REGULATORY AFFAIRS

DRUGS
Since the great majority of CIT’s clients are from the pharmaceutical industry, the teams have developed long experience in the different regulatory requirements for all classes of drugs. The Department can offer assistance in the preparation of:

• Investigator’s Brochure
• IMPD, IND, NDA on CTD format
• Expertise on specific toxicological issues
• Experts synthesis to support due-diligence

CHEMICALS
Due to the broad personal experience acquired in France and abroad, we can offer assistance in registration of chemicals within and outside the European Union.

Our Regulatory Affaires Department prepared notification dossier according to the sixth and the seventh amendments as soon as they were published. The services include:

• Pre-evaluation of your project with discussion with the authorities, if necessary, in order to set up the best (and most cost effective) set of studies.
• Project coordination, preparing with you an agreed time frame and structure.
• A complete set of studies with full GLP compliance.
• The summary dossier (SNIF) and risk evaluation
• Submission of the dossier to the authorities and follow-through until it is accepted.

Within the frame of the REACH legislation, we can offer Operational Services directed towards Manufacturers / Importers and Downstream Users such as:

• Inventory of existing substances including intermediates / substances in preparations or articles,
• Updating of notified substance data,
• New substance registration support,
• Identification of the scope of application of the REACH regulatory directive
• Portfolio analysis: information gathering, data gap identification, identification of potential substance requiring authorization, cost estimation, raw materials supply continuity, clarification of the use and exposure categories,
• Pre-registration: registration process strategy, data-base surveys and industrial intelligence,
• CBI (Confidential Business Information) - CIT can act as a central independent point of contact for registrants and downstream users, to ensure protection of confidential business information within SIEF and/or Consortia,
• Consortia formation / management,
• Substance use inventory, downstream supply chain analysis,
• Testing: development of intelligent testing strategies, waiving opportunities,
• Formatting of the data in IUCLID 5,
• Risk assessment: CSA / CSR,
• Exposure scenarii, risk characterization, labelling and classification proposals according to GHS, permanent data updating,
• Risk management: edition of SDS and permanent data updating,
• Socio-economic risk analysis for substances subjected to Authorization / Restriction,
• Central point of contact for the REACH Agency.

These services cover also other legislations including those for:

• Plant protection products
• Biocides
• Food and feed additives/product in contact with food/novel food…
• Cosmetics
• Consumer products