Developing strategic approaches to product approval strengthens the support and success each product achieves. WEMANITEC offers exceptional knowledge, understanding and insight into:
- Working with regulatory agencies as you move toward gaining approval/CE mark (or FDA [USA], PMDA [Japan] or SFDA [China] approval).
- Required bench, preclinical and clinical testing.
- Preclinical and/or clinical studies, if required.
- Selection and contracting of clinical partners, principal investigators and compliance professionals.
- Planning and support for scientific publications and various additional communication strategies.
- Postmarket surveillance activities.
The experts at WEMANITEC also:
- Specialize in health economics, to help evaluate the value of a therapy and determine potential and maximum reimbursement prices.
- Develop customized solutions that address public and private market access and reimbursement objectives.
- Provide strategic and conceptual support for health technology assessments (HTAs) in Europe and Japan
Please contact us for more information.