Connecting Excellence in Pharmaceuticals with Health AuthoritiesYour 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 onto one buisiness entity.
The company was created in response tothe growing demand for our individualservices, which we have now united inone place.
The beginning was modest, but over timewe have developed as a team andconnected more and more in order toprovide the client with the maximum ofour services.
This development continues and wehope to keep up with the constantchanges.
We focus on building a compliance-focused culture, stayinginformed about regulatory changes, conducting risk assessments,and integrating regulatory requirements into business strategyand product development.
Future projects are such to include proactive engagement withnew technologies, expanding into new markets, or developing newproducts, all supported by a robust regulatory framework toensure safety and market access.
Develops a strategic planfor your product's marketentry, including a gapanalysis to identify missingdata or documentation.
Provides real-timetracking andinterpretation ofregulatory changes toensure ongoingcompliance.
Prepares you for and manages communication with health authorities to
get feedback on development plans.
Conducts regulatoryassessments for existingproduct portfolios,mergers, acquisitions, andlicensing 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
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
CE marking: Facilitates the process for products sold inthe European Union.
Quality management systems (QMS): Helps implement and maintain quality systems, such as ISO 13485, 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
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
