Chemistry/Manufacturing/Controls, Clinical R&D, Electronic Submissions Preparation, Medical Devices/Combination Products, Medical Writing, Regulatory Affairs/Regulatory Strategy, Regulatory Document Preparation, Rx to OTC Switch, Trial Management
RegAff- A Comprehensive & Customizable Regulatory Affairs Service enabling Strategy, Execution & Compliance, with a leading role in “Pharmerging” markets.
Global Regulatory Affairs
Populated by regulatory affairs people with many, many years of experience in the Pharma Industry with extended networks
Partnered with specialist companies, eg pharmacovigilance, medical writing, statistics and e publishing
Capability: Pharmaceuticals/Biologicals/Biosimilars/Medical Devices/Diagnostics/Cosmetics
Capability and experience to provide a full regulatory service (strategic, tactical and operational) capable of handling successfully products thro development, approval for marketing and post-approval
Focused on “Pharmerging” growth countries in Asia, Latin America and the Middle East.
Country-based resources with the ability to act as a country Regulatory Agent
Strong operational base in North America and Europe
Japan and China
Full development including Regulatory Clinical Trials design and delivery and Regulatory Affairs
Benefit of working with RegAff
RegAff can operate as a global partner yet our size allows us to be efficient and flexible. We are one contractor with globally recognized leaders from their big Pharma experience :
Central resources with multiple successful regulatory experiences.
Country based resources and local RegAff companies that can act as local regulatory agents to satisfy the local legal requirements.
Consultancy Board with senior ex-health authority and Pharma Industry Members
Small and large molecule regulatory expertise.
Globally experienced, Singapore-based Chief Medical Officer that can handle any Asian clinical study requirements and, if required by the Client, product complaints and adverse reaction reports during marketing.
Global Regulatory CMC experience and guidance to manufacturing source changes
Local CRO in China and Japan for conducting local regulatory clinical studies
Alliances with local CROs in Russia and India enabling Client ‘one stop shopping’ for local regulatory and development needs.
Pharmacovigilance and full safety reporting services
Regulatory writing of all parts and types of regulatory dossiers
Full global eCTD preparation and submission capabilities
For more information about RegAff visit www.regaff.com
US phone: 1 800 855 0323(toll free) or 1 203 629 6232
UK phone : 0800 024 8689 (toll free) or +44 161 870 6224