Partner
Tightly linked to one of the most dedicated CROs in Europe, to a knowledgeable and dedicated pharmacovigilance expert team and to a very skilled European consulting company FGK is perfectly fitted to support the complete life cycle of your health product.
FGK Clinical Reasearch GmbH is a full service contract research organization offering a complete range of clinical development and consulting services to pharmaceutical, biotechnology and medical device companies and is located in Munich, Germany.
FGK Clinical Research GmbH
Heimeranstrasse 35
80339 Munich
Germany
www.fgk-cro.com
FGK Pharmacovigilance GmbH is close-knit team of professionals offering vigilance services in support to pharmaceutical, biotech, and medical device companies’ obligations in managing risk-benefit profile of their products.
Services can be added to the existing vigilance system of a client on a modular basis or comprise a stand-alone center of product vigilance on national, international or global level.
Granzer Regulatory Consulting & Services, a Munich-based company, provides strategic and operational input for drug and device development and all elements of regulatory affairs, including a sound regulatory strategy. They can define the right time for the first contact with the relevant regulatory authorities in Europe and the United States and facilitate the first contacts, help prepare briefing packages for authority meetings and accompany all phases of interaction, including dossier preparation and full regulatory submissions. Granzer tracks applications, facilitates, prepares and moderates authority meetings in national, mutual recognition including arbitrations, referrals and centralized procedures and provides the right support for filings and contacts with the FDA.
Granzer Regulatory Consulting & Services
Kistlerhofstr. 172C
D-81379 München
Germany
www.granzer.biz
MyData-TRUST is a company specializing in data protection, exclusively dedicated to the life sciences sector.
Unique combination of IT, Legal and Clinical experts provide a full coverage of services: Consulting, implementation, solutions, and on-site consultancy.
MyData-TRUST was created to assist organisations in the healthcare sector in their compliance with various international personal data protection regulations, particularly the GDPR.
www.mydata-trust.com