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SINCE2020
About our Company

AdCon MD

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.



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REGULATORY STRATEGY AND INTELLIGENCE

1. STRATEGIC PLANNING & CONSULTING

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.


PRE-MARKET AUTHORIZATION AND SUBMISSIONS

2. PRODUCT DEVELOPMENT & SUBMISSIONSUPPORT

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

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POST-MARKET AND LIFECYCLE MANAGEMENT

3. LIFECYCLE MANAGEMENT

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


Specialized services by industry

4. SPECIALIZED SUPPORT

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

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Integrity and Honesty
25%
Accuracy and Completeness
25%
Confidentiality
25%
Accuracy and Completeness
25%
Core Professional Values

Company values

  • Integrity and Honesty: Upholding ethical standardsand being truthful in all business dealings andcommunications.
  • Accuracy and Completeness: Ensuring that allinformation, whether written or oral, is correct andcomprehensive.

  • Confidentiality: Protecting entrusted sensitiveinformation.

  • Accountability: Taking responsibility for one'sprofessional work.




OUR COMPANY
PERFORMANCE

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Over 100+

MD/IVDREGISTRATIONS

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Over 20+

WHOLESALE TRADEPERMITSFOR MD/IVD

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Over 100+

FOOD SUPPLEMENTS REGISTERED

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SUCCESEFULOBTAINING ISO13485 ANDSERBIAN 3”A”MARK



Services we provide to clients

ACTIVITIES AND SERVICES