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.
SERVICES
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.
We offer:
- Regulatory advice and strategic planning of drug development.
- Preparation of meetings with regulatory authorities at important milestones of development.
- Writing of documentation in the context of scientific advice meetings with agencies in Europe, US and Health Canada including organization and support of meetings with Agencies
- Clinical trial design and support of documentation, eg regulatory support of clinical protocol generation, IB writing, submission of clinical trials
- Support of marketing application for Europe and US
- Orphan drug designations for Europe and the US
- Due diligence for developments of small molecules and biologicals
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.
EXPERIENCES AND ACHIEVEMENTS
Regulatory Affairs Strategies and Services, EU, US and Canada for more than 30 projects of more than 20 clients.
AEREAS OF EXPERIENCE
- Scientific Advice procedures (EMA and national European Agency) IND related procedures (FDA) and milestone meetings, meetings with Health Canada.
- Establishment of an international regulatory affairs department (EU/US).
- Team-member of various interdisciplinary development teams for small molecules, biologicals, vaccines, advanced therapy products and herbals.
- Member of the company’s product development committee.
- Regulatory strategies for various medicinal product developments.
- Regulatory support at key clinical opinion leader meetings.
- Project management and preparation of MAA and NDA/BLA registration dossiers for small molecules, biologicals and herbal drug products.
- Regulatory support during approval processes and regulatory maintenance.
- Application for and maintenance of internationally conducted clinical trials from Phase 1 to Phase 4.
- Review and writing of clinical trial documentation e.g. Investigator’s Brochures and Investigational Medicinal Product Dossiers.
- Due diligence processes – Evaluation of projects, generation of alternate development scenarios.
- Orphan drug designation applications, EU and US.
- Advanced Medicinal Product classifications.
WORK EXPERIENCE
- 2009 to date
Founder of „Regulatory Strategies & Pharmaceutical development“ - 2008 to date
Consultant at Granzer Regulatory Consulting & Services - 1999 to 2008
Global head of the Regulatory Affairs department, MediGene AG, responsible for EU and US regulatory strategy and submissions, CTA/IND and MAA/NDA processes Member of the companies Drug Development Committee - 1996 to 1999
Independent consultant Regulatory Affairs - 1989 to 1992
Postdoctoral Fellow, Rockefeller Research Centre of Memorial Sloan Kettering Hospital, New York City (USA), DFG Postdoctoral Fellowship - 1988 to 1989
Postdoctoral Fellow University of Milano (Italy), EMBO Postdoctoral Fellowship, octoral Fellowship, University of Milan, Italy
AFFILIATION
- Since 2002
Member of the Drug Information Association (DIA) - Since 2004
Member of the German Association for Regulatory Affairs - From 2002 to 2008
Member of the European Biopharmaceutical Enterprises group of EFPIA
UNIVERSITY EDUCATION
- PhD in Biochemistry, Ludwig-Maximillian-University, Munich, Germany
- Diploma in Biology, University of Konstanz, Germany
PRESENTATIONS GIVEN
| 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) |
PARTNERS & LINKS
PARTNERS
Granzer Regulatory Consulting & Services
www.granzer.biz
MC Toxicology
toxicology.cc
Sigi Duerr
Quality Consultant, QA Services to pharma/biotech companies to comply with EU regulations
Voglweg 6
D – 82319 Starnberg
Widler & Schiemann AG, Clinical Quality Management
Weinberghöhe 10 B
CH – 6300 Zug
www.wsqms.com
Hecker & Associates (US)
www.hecker-associates.com
LINKS
European Commission – Public Health
http://ec.europa.eu/health/documents/eudralex/index_en.htm
European Medicines Agency
www.ema.europa.eu
Institut für Arzneimittel und Medizinprodukte (BfArM):
www.bfarm.de
International Conference of Harmonization (ICH):
www.ich.org
Medicines and Health care products Regulatory Agency (MHRA), UK:
www.mhra.gov.uk
Paul-Ehrlich Institut (PEI):
www.pei.de
U.S. Food and Drug Administration (FDA):
www.fda.gov
CONTACT
Regulatory Strategies
Located in the urban Agglomeration of North Rhine Westphalia
(Dortmund, Cologne, Bonn, Bochum, Düsseldorf, Essen)
Dr. Irene Gander-Meisterernst
Schulstraße 10
48149 Münster
Tel: (+49) 0176 272 676 08
E-Mail: igm@regulatory-strategies.com
