Our Services

Regulatory Affairs

OWLPHARMA features a broad range of national and international regulatory services for medicinal products, in compliance with the applicable legislation.

Our Services include:
  • Marketing Authorisation applications (MAAs) preparation and management
  • MA variations and renewals preparation and management
  • MA dossiers preparation, review and audit
  • eCTD MA dossiers conversion
  • Medical writing / Expert reports
  • Environmental risk assessment (ERA)
  • SmPC, PIL and Labelling writing and review
  • Readability testing and Bridging reports
  • Data entry and maintenance of products via XEVMPD
  • Promotional and advertising review and notification to competent authorities
  • Price and reimbursement applications
  • Product launch and marketing support in Portugal
  • Local representatives and liaison with competent authorities