Regulatory Affairs - Informed by Experience, Driven by Expert Strategy
Helping You Create a Healthier World by Instilling Confidence in Your Submissions.
Regulatory considerations are a critical part of your clinical research program from beginning to end. With insight gained through years of experience, we develop regulatory strategies that help your trials run smoothly and meet your timelines. Whether your new product is a drug, biologic, device, or a combination product, we understand the nuances of regulatory requirements and have the resources and proven expertise to address your specific needs.
Our regulatory services are available for a wide range of authority submission deliverables, including:
Regulatory authority meetings (EMA scientific advice and protocol assistance, FDA pre-IND meeting, parallel scientific advice (FDA-EMA))
To facilitate transparency, our technology platforms keep sponsors informed about the status of country submissions and empower them to track progress of study operations. We actively utilize several electronic submission portals, including Eudralink, CESP and MHRA e-Submissions Portal.
Regulatory Affairs Consultancy
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 successfulmarketing approval of 43different 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 and 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.