Acceptance of study results by the Regulatory Authorities is the prerequisite of further development of your assets. Whether you plan to out-license your molecule or bring it to the market yourself, regulatory compliance is obligation, not a choice.
We offer:
As the drug / device development and clinical trial landscape keeps evolving, continuing professional development is a must to stay competitive. We offer numerous courses tailored to our clients’ needs. Courses on high demand include:
If you wish to publish the results, your manuscript must follow the Journal’s Guide for Authors and capture the audience. We offer medical writing expertise to save your time.
Implementing a robust Quality Management System with a risk-based approach is key to your compliance and success. Whether you wish to build your QMS from scratch up upgrade the existing one, we offer expert advice to achieve your objectives as well as independent audits of your processes.
Working with the right vendors is vital to ensure they perform to your quality standards. We offer vendor qualification and re-qualification audits as well as training in developing risk-based vendor oversight plans.
Following fitting Standard Operating Procedures helps teams to comply with regulatory requirements, work effectively and efficiently. We offer SOP gap analysis and advice for developing or revising your SOPs.
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