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EuDRAcon’s comprehensive regulatory services |
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EuDRAcon is able to provide sound strategic advice during early product development in planning for an eventual regulatory approval. Naturally, leadership can be provided in preparing the necessary documentation for submission and in handling the day-to-day communications with the authorities during the assessment phase of the procedure, both at the national and European level.
Even in the situation where a regulatory submission has been refused, EuDRAcon would be pleased to advise on a suitable strategy for overcoming the refusal and provide leadership in preparing for and presenting an appeal to the appropriate regulatory authority.
EuDRAcon can also help with the regulatory life cycle maintenance including variations and renewals, as well as with relevant post-approval activities, such as distribution model design, pricing & reimbursement, pharmacovigilance, promotional review and approval.
EuDRAcon has specialists experienced in many product types and therapeutic areas. These include medicines (both human and veterinary), medical devices, food supplements, herbals and cosmetics. All the relevant scientific disciplines are covered by consultants within EuDRAcon, such thatadvice can be provided on technical as well as regulatory matters.
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