Regulatory Affairs

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.



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

Market Maintenance

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

Contact us

Contact us for inquiries about Regulatory Affairs