PharmaExpert in Austria e.U. is a registered pharmaceutical consultancy based in Austria providing health care companies with assistance in a wide range of services.

The mission is to provide professional assistance in pharmaceutical project management to the pharmaceutical companies and medical device companies through long-term client relationships.

PharmaExpert in Austria e.U. guarantees a pro-active approach, rapid decision-making and clear communication on all your projects. The price-performance ratio will convince you.

Core competencies:

• Quality Management, Pharmaceutical Quality Assurance: consultancy, buildup and  implementation of QMS concerning ISO 9001:2008 – GDP, GCP, GMP
• Risk management
• Audits, self-inspections: internal/external audits of QMS, processes, clinical trials or cites,vendors,etc.
• Pharmacovigilance for human and veterinary medicinal products and medical device-vigilance: Pharmacovigilance System, adverse event notification process, Qualified Person Pharmacovigilance services, Eudravigilance Database certificate
• Medical Writing Services, Medical Information
• Clinical Trials, Investigational Medicines: Planning and management of clinical product development
• Medical Devices: Consultancy and registration procedure, classification and expertise
• Regulatory Affairs, Medical Affairs, license applications, authorisation documents, etc.
• Services as Managing director according to Austrian trade regulations for manufacturing of drugs, drug distribution and trade
• Information officer services