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Germany - Dr. Regenold GmbH |
International Reg. Aff. Manager
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Dr. Regenold GmbH
Am Berg 4
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Badenweiler |
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79410 |
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Germany |
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Dr. Regenold GmbH is specialized in the efficient management of international marketing authorisation procedures for drugs. We guarantee a pro-active approach, rapid decision-making and clear communication on all your projects.
Areas of expertise - National Marketing authorisation application within the EU, GUS and USA and international procedures (mutual recognition or centralised procedures within the EU). Orphan Drug designation applications and marketing authorisation applications. Scientific advice consultations with Regulatory Authorities. Design and management of drug development projects. Planing and performance of observational studies.
Services offered - Full range of Regulatory Affairs related services, GMP training, MR-procedures, Orphan drug application, centralised procedures, Licensing In/Out, drug development,regulatory services for medical devices.
Countries served - Germany and, in cooperation with local R+ members, all other countries served by regulanet.
Year founded 1994.
35 staff members (Pharmacists, chemists, biologists, physicians, technical assistants, administration) |
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by Zdravko Mauko 0 replies.
by Zdravko Mauko 0 replies.
by Zdravko Mauko 0 replies.
