DREHM Pharma GmbH

DREHM Pharma was founded 1997 by Dr. Ewald H. Moser, first as one-man-business and then upgraded to a limited liability company in 2004.

Since that time, the team that Dr. E.H. Moser started grew to offer a complete range of services.
Today, 23 employees offer expertise in the following areas:

Regulatory Affairs - Drugs:
National and EU-Procedures (DCP and MRP)
Life-Cycle-Management
Updates of existing dossiers
Writing complete dossiers
Project Management
Writing and updating product informations
Translation of product information in German, English and French
Readability tests
Medical Writing

Regulatory Affairs - Food Supplements:
Creation and evaluation of labels, product information and promotional material
Due diligence evaluation with EU-law

Pharmacovigilance:
XEVMPD – Third Party Service Provider
Entire maintenance of Pharmacovigilance
PSURs
Assessment of ICSR's
Writing RMPs
Providing and maintenance of a Pharmacovigilance database – (PcVmanager from EXTEDO)
Registration of companies at EudraVigilance
Updating Pharmacovigilance - Systems
QPPV position

Quality Management:
Intermediation of analytical laboratories
Batch Release
QP-Services
QM-Systems
Audits and Inspections

Given the transparent company structure, personal support and contact with each client is ensured.
The company is located in the heart of Europe: Vienna, Austria.

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Specialties : 

Status: 

Operating

Industries: 

Employee Count Range: 

11-50

Company type: 

Partnership

Founded year: 

2004

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