Regulatory services

We offer to our partners to build the regulatory strategy for registration of medicinal products and help them to obtain the Marketing authorizations.

Our services include:

Consultations on Bulgarian and European legislation related to medical devices

We provide consultations regarding the current Bulgarian and European legislation for medical devices, in order to ensure compliance and successful market access in short terms.

Our services include:

• Preparation of notification for placing on the market
• Review of packaging materials to ensure compliance to legislation requirements
• Review of advertising materials for medical devices
• Regulatory activities related to import/export of medical devices
• Verification of compliance of the medical devices dossier

Regulatory procedures for registration of food supplements.

We provide professional services for registration of food supplement. We ensure compliance of food supplements to current legislation to help our clients to achieve fast and successful market access

Our services include:

• Preliminary examination of the text of labels and verification of their compliance with regulations
• Identification of claims that can be used
• Review of packing materials
• Review of advertising materials
• Assistance in obtaining Free sale certificates
• Assistance for import from European and Non-EU countries

Designation of an EU Responsible Person (EU RP) for cosmetic products.

We offer specialized services for cosmetic products registration – designation of responsible person (EU RP) and compliance with the requirements of the European Commission for cosmetic products.

Our services include:

• Product formulation review and assessment of compliance with EU legislation
• Product Information File (PIF) safety assessment
• Labeling review and assessment
• Notification in the Cosmetic Products Notification Portal (CPNP)
• Post-market surveillance (Cosmetovigilance) to ensure long-term compliance and safety of cosmetic products