regulatory affairs

Comprehensive regulatory support for the Serbian market

A strategy tailored to your goals

At Bonifar, we provide support at every stage of regulatory processes covering the entire product lifecycle, ensuring smooth and compliant access to the Serbian market. Acting as the local Marketing Authorization Holder (MAH), we take ownership of regulatory submissions, dossier preparation, and communication with the Agency for Medicines and Medical Devices of Serbia (ALIMS).

  • Deep knowledge of ALIMS procedures
  • Compliance with EU standards
  • Ethics, transparency and efficiency

“Our proactive approach helps minimize delays and regulatory risks, enabling partners to focus on business growth while we manage the complex regulatory landscape efficiently and ethically.”

Regulatory strategies

We guide our partners through local adaptations, ensuring their products meet all safety, quality, and efficacy standards.

Pharmacovigilance

Ongoing safety monitoring, timely adverse event reporting, and risk management to protect patients and maintain regulatory compliance.

Life cycle management

Lifecycle management, such as maintenance, variations, renewals, and regulatory compliance monitoring.

become our partner

Need expert help with regulation?

Contact us to review your portfolio and create the optimal strategy for launching your products in Serbia.

Schedule a meeting