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Regaff Pte Ltd

Description: 

 

 

 

RegAff- A Comprehensive & Customizable Regulatory Affairs Service enabling Strategy, Execution & Compliance, with a leading role in “Pharmerging” markets.

                                                       Global Regulatory Affairs

People

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

Business Focus

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

 

Services: 

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

Contact Information: 

Regaff Pte Ltd
3 Raffles Place, #07-01 Bharat Building
Singapore, , 048617, SGP
Phone : 82332788
Fax :
Internet : www.regaff.com
Email : george.butler@regaff.com
Contact Person : George Butler