Regulatory strategies and pharmaceutical development was founded in 2008 and has since then supported small to medium sized pharmaceutical companies developing therapeutics and vaccines for a broad range of indications. Focus of the company is the overall regulatory aspect of development from early preclinical stage to marketing authorization.
Efficient interaction of all stakeholders involved in pharmaceutical development and strategic thinking is crucial to efficient progress from early to late drug development and towards registration of biologics, small molecules, vaccines and advanced therapy medicinal products.
Use our expertise and network of partners to overcome regulatory hurdles and to go efficiently from one regulatory milestone to the next on the way towards a successful registration process.
Regulatory Affairs Strategies and Services, EU, US and Canada for more than 30 projects of more than 20 clients.
AEREAS OF EXPERIENCE
|2011||Bio M Munich, Effective scientific advice during drug development|
|2010||DIA Annual Meeting, Washington DC, Scientific Advice and Successful EU Clinical Trial Applications|
|2009||Implementation of clinical data into the registration dossier, Bio M, Munich|
|2009||Scientific advice and registration procedures for small molecules Biopharmaceuticals, Annual meeting of the Association of Clinical Pharmacology, Heidelberg|
|2008||Innovative herbal drug products, FAH, Bonn|
|2007||IMPD and IB, clinical forum of DIA, Madrid|
|2007||IMPD and IB, what additional information has to be included, Annual meeting of DIA, Altlanta, (US|
|2006||The drug development process, from start to drug registration, Annual meeting BIO-Deutschland e. V., Halle|
|2003||Decentralized European Registration Systems, BioM, Munich|
|2002||Perform Clinical Trials with Cancer Vaccines in Europe – The Regulatory Environment, The Center for Business Intelligence, Washington DC (USA)|
Granzer Regulatory Consulting & Services
Quality Consultant, QA Services to pharma/biotech companies to comply with EU regulations
D – 82319 Starnberg
Widler & Schiemann AG, Clinical Quality Management
Weinberghöhe 10 B
CH – 6300 Zug
Hecker & Associates (US)
European Commission – Public Health
European Medicines Agency
Institut für Arzneimittel und Medizinprodukte (BfArM):
International Conference of Harmonization (ICH):
Medicines and Health care products Regulatory Agency (MHRA), UK:
Paul-Ehrlich Institut (PEI):
U.S. Food and Drug Administration (FDA):
Located in the urban Agglomeration of North Rhine Westphalia
(Dortmund, Cologne, Bonn, Bochum, Düsseldorf, Essen)
Dr. Irene Gander-Meisterernst
Tel: (+49) 0176 272 676 08