Taking compounds successfully through clinical development, submission, and approval is a difficult, expensive, and lengthy process. Our regulatory consultancy provides the guidance you need to move an asset into and through a clinical trial while optimally positioning that asset for regulatory approval. Data from Pharm-Olam studies have supported successful marketing approval of 43 different indications.
With the advent of the European Union’s General Data Protection Regulation (GDPR) in 2018, we also now provide specific consulting and data protection officer (DPO) services.
A clear understanding of local regulatory environments is a key part of enabling site activation. Our regulatory strategy and submissions team is directed by leaders with global regulatory affairs knowledge, coupled with local country expertise, to help you navigate complex, ever-evolving requirements. While executing your study-specific regulatory strategy, our managers keep regulatory authority and IRB/IEC submissions on track. They will review your documents to identify potential weaknesses and proactively prepare responses. Our local experts will also prepare and review final submission packages to ensure compliance.
Operating across 60+ countries, Pharm-Olam experts are authorities on the European Clinical Trial Regulation currently being implemented as well as the 2017 EU Medical Device Regulation. Through offices in 27 countries, we provide local legal/authorized representation, and for clients without an entity in Europe, we also offer EU legal representation.
Beyond regional expertise, our regulatory teams have specific members aligned with each of our Centers of Excellence (CoE). This therapeutic insight enables our team to recognize regulatory complexities related to your compound and provide the right regulatory strategy for the indication. Therapeutic specialists are in place for rare and orphan diseases, pediatric, medical devices, GMO, and Voluntary Harmonisation Procedure (VHP) studies.
