Our experienced professionals are helping pharmaceutical and biopharmaceutical companies with regulatory affairs advice, submissions and compliance and have clients based in Europe, America and Asia.
Our regulatory team has the skills and proven ability to advise on and manage a variety of regulatory projects of all sizes. Our collaboration with a network of overseas associates strengthens our capability to run international projects. We know that even the best resourced regulatory affairs departments need additional support at peak times and our team has gained a reputation for delivering projects on time and within budget for clients across the world.
Relentlessly striving to exceed our clients’ expectations, we enable you to remain focused on your key objectives while taking care of your short-term or long-term regulatory needs.
J&P MEDICAL RESEARCH Ltd. cooperates with other medical departments and also performs clinical trials in emergency situations involving subjects who are potentially incapable of giving their consent. For more detailed information please see §43a (2) of the Austrian Drug Law.
Our outstanding reputation stems from diligently focusing on planning and conducting scientific studies, pharmacokinetic and statistical analyses, clinical trial monitoring and the preparation of standardized medical documents.
We offer you the full range of servicesregarding (pre-)clinical trials. Depending on your needs we provide the following services to your institute:
Ethics committee of the Medical University Vienna
ECDC – European Centre for Disease Prevention and Control
AGES – Agentur für Gesundheit und Ernährungssicherheit GmbH
DHHS – U.S. Department of Health and Human Services Eudra CT
EMEA – European Medicines Agency
ICH – International Conference on Harmonisation