Regulatory Affairs

Strugopgharm regulatory team is comprised of regulatory professionals with broad global and local regulatory knowledge, needed to develop regulatory strategies that enable the most efficient and fast registration pathway(s), anticipate, and resolve potential challenges.
Our professionals ensures quality submissions to maximize the likelihood of successful review.
We offer a complete spectrum of comprehensive Regulatory Affairs services including:

• Appointed pharmacist / regulatory affairs manager
• New drug and medical devices registration (fast to market approach), dossiers preparation, submission, and handling during the health authority review
• Life cycle management (renewals, variations, safety updates etc.)
• Line extensions, new indications
• Facilitate interactions with health authorities on regulatory issues and respond to health authorities questions
• Labeling and Packaging with localization (patient leaflets, labels, packages, etc.)
• Promotional materials/activities for public and medical community