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
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.
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
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
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
We have a golden track record of meeting recruitment targets for sponsors.
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News for Patient Recruitment
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The Importance of Scientific Advice from the Regulatory Authorities in Clinical Research
The process of marketing authorization is a crucial step in the entire drug development process. Deciphering the most...
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Ebook’s title comes right here
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Ebook’s title comes right here
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Maecenas interdum gravida purus quis dictum.
Learn more
