Adress
Heidelberger Str. 32c
D-69198 Schriesheim
Mail & Web
info@helionpharma.com
www.helionpharma.com
Phone
+49 (0)176 8123 0027
According to your needs, we provide a wide range of services:
Clinical Development and Drug Regulatory Affairs
„What is not documented, was not done“ – documentation is key for effective drug development.
I offer “de novo generation”, review, optimization and updating of all documents related to clinical development:
Effective drug development requires planning of quality assurance (QA) and quality control (QC) throughout the development program. Small issues during the course of drug development often result in big issues in the marketing approval process. Rather than fixing issues after their occurrence, preventing issues may be a better strategy.
Founder of Helion Pharma Dr. Witte
Founded Helion Pharma as consultancy in 2008. Recent success examples include:
– Restructuring of „failed“ clinical project to successful clinical proof-of concept– Coordinated clinical and regulatory activities from preclinical to completion of first in human study
Developed and implemented infrastructure for global clinical development, pharmacovigilance and medical affairs in a small company setting as Chief Medical Officer of Nitec Pharma
More than 15 years experience in biomedical research: clinical studies in phases I-III, design and implementation of large and small clinical development programs in indications relating to inflammation, respiratory, rheumatology, pain and gastroenterology
Successful interaction with relevant regulatory authorities in EU/US, including scientific advice, pre-IND, and end of phase 2, pre NDA & registration meetings
Coordinated clinical activities of the global development and registration of Lodotra/Rayos of Nitec Pharma
Designed and implemented large global clinical development programs as clinical program leader at ALTANA Pharma
Graduated in biochemistry & immunology, postgraduate studies in pharmaceutical medicine
Founded Helion Pharma as consultancy in 2008. Recent success examples include:
– Restructuring of „failed“ clinical project to successful clinical proof-of concept
– Coordinated clinical and regulatory activities from preclinical to completion of first in human study
Developed and implemented infrastructure for global clinical development, pharmacovigilance and medical affairs in a small company setting as Chief Medical Officer of Nitec Pharma
More than 15 years experience in biomedical research: clinical studies in phases I-III, design and implementation of large and small clinical development programs in indications relating to inflammation, respiratory, rheumatology, pain and gastroenterology
Successful interaction with relevant regulatory authorities in EU/US, including scientific advice, pre-IND, and end of phase 2, pre NDA & registration meetings
Coordinated clinical activities of the global development and registration of Lodotra/Rayos of Nitec Pharma
Designed and implemented large global clinical development programs as clinical program leader at ALTANA Pharma
Graduated in biochemistry & immunology, postgraduate studies in pharmaceutical medicine
Heidelberger Str. 32c
D-69198 Schriesheim
info@helionpharma.com
www.helionpharma.com
+49 (0)176 8123 0027