Regulatory Affairs

The drug and medical devices registration is one of the services we offer to our partners. Extensive experience we possess in regulatory affairs is the result of our many years of registering and placing a large number of brands in the local markets with success.

Our drug registration service is based on our continuous monitoring of regulations, product life cycle tracking, exceptional familiarity with the regulatory processes and our long-standing close communication with regulatory institutions and agencies.

By closely monitoring the current legal regulations in this field, we are able to offer you a comprehensive solution encompassing the following activities, which precede the registration stage:

• Preparation of application dossier in CTD format to align with National procedure requirements in Serbia
• Expert Technical Support in preparation of documentation according to local requirements
• GAP analysis
• Translation of necessary documentation and submission to the relevant institutions
• Proposed labelling for inner and outer packaging
• Drafting of product summaries (SmPC) and packaging leaflets (PIL/IFU)
• Approval of local product information and labelling
• Following up on the registration process until the drug and medical device sales & marketing license is received
• Amendments of registration documents
• Liaison with local NCA in preparation, progress monitoring and obtaining MA

Maintaining MAs throughout the product cycle Post-registration stage:

• Variations
• Renewals
• SmPC/PIL/IFU drafting/validation/approvals...
• Packaging and labelling compliance
• Marketing authorization transfer
• Expert opinions

Referent procedures:

• EU- CP, MRP, DCP, EU National

Product areas:

• Medicines

• Innovative products
• Generics
• Herbal
• WEU
• Orphan
• Biologicals
• Immunologics...
• All prescribing regimens (Rx/OTC)

• Medical devices

• classes I, IIa, IIb, III
• non-invasive, invasive, active
• Transient to Long-term application
• Registration of MD manufacturersYOUR CONTACT

Regulatory inteligence     

• Legal advices
• Regulatory strategy
• Monitoring regulation changes and updates
• Evaluation and updating regulatory/safety documents
• Regulatory and safety compliance
• Meetings with NCAs

Pharmaco)vigilance experience

(Pharmaco)vigilancePV  experience

• Development and maintaining of the Local (Pharmaco)vigilance system
• Local QPPV and back ups
• 24h/7d/w (P)V coverage
• Timely local ADR submissions
• Follow ups queries with primary reporter
• Processing of product QN, PRI, PSI, PRN, FSCA…
• PSUR/RMP/aMMR submission
• Implementation of aMMR, DHPC
• Implementation of safety variations
• Archiving of source documentation
• Reconcilliations
• Local medical literature reviews
• Trainings
• Maintaining PV and Quality SOPs
• Deviations, CAPAs and Change Control management
• Audits
• Coordinating recalls and market withdrawals with NCA and distributors
• Data protection