Accelerate your Submission and Approval Timelines with Dokumeds’ Expertise

Our extensive knowledge of local rules and practices across the world will help get your product through its lifecycle efficiently.
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Regulatory Affairs CRO

Dokumeds offers a full range of regulatory services and expertise.  From Clinical Development strategy, Regulatory Framework and Clinical Trials Applications to Periodic Reporting and Marketing Authorization.

Our deep understanding of local frameworks ensures that we keep on top of the changing environment across Europe and other regions.

Clinical trials approval:

  • Clinical trials (with medicinal products and medical devices) and non-interventional studies authorization applications
  • Authorization maintenance and support

Marketing authorization:

  • Support in marketing authorization applications
  • Marketing authorization maintenance
  • Gap analysis

Other:

  • Wide range regulatory consultancy
  • Medical writing
  • Translations

Connected services

Pharmacovigilance Icon
Pharmacovigilance
Proven solutions and quality, with services designed to ensure patient safety at every stage of the drug life cycle.
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Clinical Operations Icon
Clinical Operations
Highly nuanced approach that accounts for the specific needs of each project.
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Feasibility
We have been Feasibility Specialists for over 20 years. Sponsors contact us for specialist regional feasibilities, and oversight of global feasibility studies.
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Patient Recruitment
Patient Recruitment
We have a golden track record of meeting recruitment targets for sponsors.
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