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