We help pharmaceutical companies overcome critical regulatory affairs challenges and provide them ongoing hands-on regulatory support. From regulatory strategy and dossier development to registration and full life-cycle management activities, our commercially-minded team ensures high quality work, maximum compliance and timely approvals globally.

Insuvia can act as your full-service regulatory department, as well as address more specialized needs:

  • Regulatory Strategy 

  • Dossier Gap Assessment and Due Diligence (Pre-Submission / Pre-Acquisition / In-Licencing) 

  • Dossier Writing – non-clinical and clinical overviews and summaries, quality overall summaries 

  • Marketing authorization applications 

  • Assistance with all submission procedures 

  • PIL readability user testing 

  • eCTD publishing 

  • Product Lifecycle Management (renewals, variations, Rx/OTC switch, MA transfers) 

  • Local Regulatory Representation 

  • Management of product information (translations, editing, proofreading, etc.) 

  • Promotional material regulatory compliance 

  • Management of Artworks & Labelling 

  • Market Access and Reimbursement support 

Regulatory Affairs Outsourcing Solutions

Outsourcing solutions to solve key challenges encountered throughout the journey of product development and commercialization.

Local Regulatory Affairs Outsourcing

Local regulatory support to assure regulatory compliance and maintain licences through product life-cycle.
Read more

Marketing Authorization Applications

Regulatory strategy and marketing authorization services aimed to achieve fast and smooth regulatory approvals.
Read more

Regulatory Dossier Writing

Medical writing and Dossier development services covering all documents from Module 1 to Module 5.
Read more