PHARMA
GDP-MANAGEMENT

INTERIMS MANAGEMENT – PROJECT MANAGEMENT

• Professional qualification for the wholesale trade in pharmaceuticals in accordance with the legal requirements for the regulated trade in manufacturing of pharmaceutial products and the wholesale of medical and pharmaceutical products, Austrian Law BGBl. II No. 128/2003.

• Professional qualification for the commercial law management of a pharmaceutical company in accordance with §94 GewO (Gewerbeordnung), in accordance with § 63 (1) AMG (Arzneimittelgesetz) and in accordance with § 10 AMBO (Arzneimittelbetriebsordnung).

• Founding service of a national branch for international companies (SOPs, AMG, AMBO, GDP).

• Evaluation and preparation of GDP compliant storage and transport systems.

• SOP creation, maintenance and training of employees and external partners.

• Audit services internally (employees) and externally (suppliers) as well as assistance with official audits.

• Creation and support of quality systems (QM manual)

• Preparation for ISO 9001: 2015 certification.