Our Mission

As a Global Specialist Regulatory Affairs (only) company, to become 1st choice for:

• Global full regulatory service & consulting for small/medium sized companies
• Strategic partner to help drive growth
• Global outsourcing from Pharma driven by re-engineering
• Provide a flexible resourcing option

About RegAff

RegAff is a virtual global regulatory affairs organization providing full regulatory affairs services. We offer a tailor made service according to the client and project requirements and are flexible enough to respond effectively to changing priorities. As well as our own people we work with experienced regulatory consultants who together can offer a wide range of expertise and services. We have an increasing focus on providing a global service with RegAff resources available in key emerging and more established global markets. 

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 :

• 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 need.
  
• 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.
  
• EU Qualified Person for release of batches of product for sale.
  
• Globally experience GMP, GLP and GCP Compliance Person to carry out inspections and interact with regulatory authorities
  
• Pharmacovigilance and full safety reporting services in collaboration with a partner company.
  
• Full eCTD preparation and submission capabilities