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PMDS - Pharmed-Dev Services

Medical-pharmaceutical services and consultancy including regulatory affairs, product development, medical writing including expert reports, medical device administration, and support to clinical studies

http://www.pharmed-dev-services.com/

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PMDS - Pharmed-Dev Services | pharmed-dev-services.com Reviews
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Medical-pharmaceutical services and consultancy including regulatory affairs, product development, medical writing including expert reports, medical device administration, and support to clinical studies
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PMDS - Pharmed-Dev Services | pharmed-dev-services.com Reviews

https://pharmed-dev-services.com

Medical-pharmaceutical services and consultancy including regulatory affairs, product development, medical writing including expert reports, medical device administration, and support to clinical studies

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pharmed-dev-services.com pharmed-dev-services.com
1

PMDS - Pharmed-Dev Services

http://www.pharmed-dev-services.com/other_services.php

Other Medical and Regulatory Services. Medical writing including draft publications, brochures, assessments. Review and editing of books, articles and reports. Regulatory due diligence for licensing projects. Gap analysis of data packages / dossiers for MAA submissions. Virtual regulatory department for smaller organizations and companies. Trainings in-house or off-site. Please contact us in case of special needs. Medical writing or review.

2

PMDS - Pharmed-Dev Services

http://www.pharmed-dev-services.com/medicinal_products.php

We offer regulatory and medical support as well as clinical support for both human and veterinary medicines. Our key services include:. Strategic planning for product development. Preparation or review of strategies especially for generic products. Assessment of regulatory opportunities and risks. Review and appraisal of the regulatory environment, the relevant guidelines, existing precedents and ongoing regulatory initiatives possibly affecting the process. Support in selecting and contracting a CRO.

3

PMDS - Pharmed-Dev Services

http://www.pharmed-dev-services.com/medical_devices.php

Strategic planning for product development. Classification of medical devices and legal borderline determination (especially between medicinal products and medical devices). Identification of the Directive(s) and harmonized standards applicable to the product. Definition of the product-specific requirements. Conformity assessment procedure and risk analysis. Pre-clinical and clinical evaluation including clarification on the needs. Preparing and arranging advice meetings with Notified Body.

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