regulatory submissions

Schmidt Consultancy has over 20 years of experience with Study Start-Up and Regulatory Submissions. This enables us to quickly and efficiently obtain national and local approvals of your studies that are subject to the Medical Research Involving Human Subjects Act (WMO). We are the preferred partner of various customers, both in the Netherlands and internationally. Our clients, the Central Committee on Research Involving Human Subjects (CCMO) and medical research ethics committees are familiar with our perfect dossiers and consider us a professional, pragmatic and fully-fledged partner.

Schmidt Consultancy offers you expertise, inventiveness, pragmatism, short lines of communication, swift actions and reactions, and a personal approach.

Our services:

  • Taking care of both the central and local submission of your study that is subject to the WMO
  • Perfect ECTR-proof dossiers
  • Patient information file written/translated by us
  • Contract management
  • Outstanding collaboration with all regulatory authorities, accredited MRECs and Boards of Directors
  • Continuous progress monitoring and reporting
  • Swift actions and reactions

Hand over the protocol and we’ll do the rest! We also reduce the workload of researchers and their research departments, which means your study can get started faster.

Your benefits of hiring Schmidt Consultancy:

  • Fast results
  • Savings on manpower
  • Audit proof trail
  • Continuous availability
  • Personal contact
  • Respect for the position of all parties