Know our Regulatory Affairs Services.
Strategy, Submission and Market Maintenance.
Besides standard services, we provide critical and cross-sectional analysis taking into consideration the product life cycle.
Owlpharma features a broad range of national and international regulatory services for medicinal products as well medical devices, food supplements and cosmetics in compliance with the applicable legislation.
OUR SERVICES INCLUDE
Preparation, review and audits of MA Dossiers
Definition of regulatory strategy for approval of MAs
Preparation and conversion of MA Dossiers into eCTD format
MA and Marketing
Preparation, submission and management of MA applications (EU and non-EU)
Price and Reimbursement applications
Local Representatives of MAHs
Regulatory support in the launch and marketing of products
Preparation, submission and management of variations and renewal applications for MAs (EU and non-EU)
Product information management on the Eudravigilance Platform (XEVMPD)
Regulatory support in the advertising of medicinal products