Regulatory Affairs

Artixio provides specialized regulatory consulting and regulatory affairs services to clients from pharmaceutical, medical devices and other industries. Artixio's Regulatory Affairs team have decades of experience in bringing complex therapies to market across different therapeutic areas right from the early development to post marketing stage. 

Our Products Experience: 

Artixio's team includes regulatory experts specialized in medicinal products, medical devices, cosmetic and dietary supplements in global markets. 

Global Experience: 

With over 200 consultants in global markets, Artixio is helping its clients with regulatory affairs in all the key markets worldwide. 

The Regulatory Affairs Services include, 

  • Regulatory Strategy for Registration 

  • Pre-Submission Meeting with Health Authority (Type A, B, C Meetings and similar meetings in other countries)

  • Dossier Preparation 

  • Regulatory Writing, Clinical and Non-Clinical Writing 

  • eCTD Publishing and Submission 

  • Label Authoring and Review

  • Artwork Mockup Creation and Review 

  • Post Submission, Health Authority Query Responses

  • Authorized Agent, Legal Representation