Regulatory Strategy

Regulatory Strategy

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To help clients effectively navigate the complex regulatory landscape and meet their regulatory compliance obligations, PharSafer® support clients by preparing and submitting the varied regulatory filings world-wide, utilising scientific advice in development programs for filing strategy; monitoring regulatory changes, and understanding the various mechanisms for obtaining licences for different product types e.g., herbal; traditional; generic; OTC; innovator. Whether it be performing comprehensive regulatory compliance assessments, developing and maintaining the Global Product Labelling and Core Data Sheets or undertaking activities such as Licence extensions in new territories with new indications and formulations, our team has many years’ expertise to ensure our clients receive a first-class service.
PharSafer13Founded in 2003 by Dr Graeme Ladds, PharSafer® is a specialist Contract Research Organisation (CRO) in Global Clinical and Post Marketing Drug Safety, and Medical Services, with a wealth of experience in Pharmacovigilance, Auditing and Medical Affairs – and the various, numerous and extensive legal safety/medical obligations for licence holders to comply with – as well as Regulatory Strategy for the best methods for obtaining scientific advice concerning licence submissions and approvals. Together with our sister company which focuses on Training: SaPhar, PharSafer® continuously seeks new and innovative ways to provide added value for our global clients – going above and beyond expectations and optimising processes and procedures involved with clinical and post marketing drug safety and licencing approach. Our ability to offer first-class services in Pharmacovigilance, Regulatory Affairs, Training, Auditing, Medical Affairs and IT Informatics means that, for many clients, we operate as their Pharmacovigilance and Medical Departments – guiding them through the labyrinth of drug safety and medical legislation, all in the interests of ensuring patient safety and client compliance. We love what we do. We love finding solutions. Quite simply, we are by far... Your leading partner in Drug Safety.

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