Regulatory Affairs

toclinco understands and appreciates the influential factors which can contribute to a fruitful and successful interaction with regulators in order to achieve your targets. Strong impact factors in reaching your goals include an in-depth understanding of the clinicopharmacological properties of your product, of the medicinal product's target profile, of the culture of your organisation, of the scientific / competitive environment, of international and national regulatory frameworks and of the expectations of the regulators.

Our services may include:

  • Writing and compilation of eCTDs (Module 2)
  • Development of regulatory strategies - interactions with stakeholders (e.g. regulatory authorities, company team, and/or scientific experts)
  • Review of all clinical regulatory documents (e.g. clinical trial protocol, IB, IMPD, IND, clinical study report (CSR), overviews and summaries, ...)  
  • Composition and content of briefing packages for regulators or internal / external decision makers
  • Preparation of and support during regulatory meetings (scientific advice) - consideration of regulatory input
  • Preparation of clinical trial application (e.g. following EudraLex - Volume 10 clinical trial guidelines)