Connecting Excellence in Pharmaceuticals with Health Authorities
Your Trusted Partner in every step of Compliance
AdCon MD is founded in December 2020.as a result of previous regulatory Activitiesand with wish to combine experience andknowledge into one buisiness entity.
The Copany was founded in response to the growing demand for specialized regulatory services that clients once had to source individually — expertise we have since unified under a single, trusted partner.
What began as a modest venture has grown into a cohesive team of experts. By deepening our collaboration and integrating our capabilities, we deliver the full scope of our services with consistency and precision.
That progress continues today, as we remain committed to evolving in step with an ever-changing regulatory landscape.
We are committed to building a compliance-focused culture — staying ahead of regulatory change, conducting rigorous risk assessments, and embedding regulatory requirements into both business strategy and product development.
Looking ahead, our future initiatives include proactive engagement with emerging technologies, expansion into new markets, and the development of new products — each underpinned by a robust regulatory framework that safeguards safety and accelerates market access.

Develops a strategic plan for your product's market entry, including a gap analysis to identify missing data or documentation.
Provides real-time tracking and interpretation ofregulatory changes toensure ongoingcompliance.
Prepares you for and manages communication with health authorities to
get feedback on development plans.
Conducts regulatory assessments for existingproduct portfolios,mergers, acquisitions, and licensing deals.
Compiles and submits the necessary documentation for product approval in the appropriate format.
Manages all aspects of submissions.
Handles the publishing and technical support for e-submissions via agency gateways

-6w3i1l.jpg)
Manages all aspects of post-approval safety monitoring
Ensures all product labeling, packaging, and promotional materials comply with the latest regulations and product licenses.
Submits variations, amendments, and renewals to maintain marketing authorizations throughout a product's lifecycle.
Conducts audits, provides remediation strategies for compliance issues, and helps address agency findings
Registration Holder (MAH) for Medical Devices in Serbia
As your trusted partner in Serbia, ADCON MD acts as your dedicated local representative, fully managing these regulatory duties to guarantee seamless market access and 100% legal compliance for your medical devices.
CE marking: Facilitates the process for products sold in the European Union.
Quality management systems (QMS): Helps implement and maintain quality systems, such as ISO 13485, ISO 9001, ISO 27001, that meet regulatory standards
Post-market surveillance: Establishes systems for monitoring device performance and handling complaints after market approval
Product registration: Assists with registering theproduct with the relevant government agency.
Labeling review: Checks that all labels and claims comply with country-specific regulations.
Novel food registration: Supports the approval process for new food ingredients
-johms.jpg)
Accuracy and Completeness: Ensuring that allinformation, whether written or oral, is correct andcomprehensive.
Confidentiality: Protecting entrusted sensitiveinformation.
Accountability: Taking responsibility for one'sprofessional work.
MD/IVDREGISTRATIONS
WHOLESALE TRADEPERMITSFOR MD/IVD
FOOD SUPPLEMENTS REGISTERED
SUCCESEFULOBTAINING ISO13485 ANDSERBIAN 3”A”MARK