SOLUTIONS FOR MANUFACTURERS

REGULATORY EXPERTS

We navigate the bureaucracy for the success of your products

The authorization process is the gateway to the pharmaceutical market. Incomplete documentation can mean months of delay and financial losses.

At Lismedfarm, we completely manage the interaction with the Medicines and Medical Devices Agency (AMDM), the National Agency for Public Health (ANSP), and the National Commission for Biocidal Products. 

We offer registration and market access services, from dossier validation to authorization maintenance throughout the entire life cycle. This is part of the complex solutions offered by Lismedfarm for manufacturers.

  • 100% Compliance with national legislation
  • Reduction of approval time (Time-to-market)
Înregistrare: Medicamente, Dispozitive Medicale, Suplimente, Produse Biocide în Moldova

Areas of Expertise

Complete solutions for the entire health portfolio

Medicines

  • Primary and repeated authorization (National, Recognition, Simplified, etc.)
  • Management of variations (IA/IAIN, IB, II)
  • Translation and adaptation of SmPC & Leaflet
  • Dossier evaluation

Medical Devices

  • Registration in the State Register (RSDM)
  • Verification of CE marking and conformity
  • Medical devices vigilance system
  • Graphic design of labels and packaging

Biocidal Products

  • Registration at ANSP (National, Recognition)
  • Product Type Classification (TP1-TP22)
  • Preparation of the dossier according to national requirements
  • Specific labeling

Food Supplements

  • Notification/Registration at ANSP
  • Verification of admitted ingredients
  • Health Claims
  • Verification of labeling compliance

Cosmetic Products

  • Notification at ANSP
  • Product safety assessment
  • Elaboration of Safety Report (CPSR)
  • Validation of packaging content

Critical Services for Market Access

Without these elements, commercialization is impossible or illegal

Pharmacovigilance (LPPV)

The medicine authorization holder is obliged to have a person responsible for pharmacovigilance at the local level (LPPV). Lack of LPPV can lead to authorization suspension.

  • Qualified LPPV person available 24/7.
  • Monitoring local literature and ICSR reporting.
  • Management of pharmacovigilance inspections.

Manufacturer Price Registration for Medicines

Authorized medicines can only be imported if the price is registered in the National Catalog of Prices (CNP).

  • Preparation of the price registration dossier according to methodology.
  • Justification of the price before AMDM.
  • Management of the mandatory annual review.

Authorized Representative for Medical Devices

Manufacturers from outside the country are required by law to designate a local authorized representative for medical devices.

  • Legal point of contact with AMDM.
  • Storage of technical documentation and declarations.
  • Management of safety actions (FSCA) and vigilance.

Advertising Approval

Any promotional material for medicines (TV, print, digital, congresses) requires prior approval from AMDM.

  • Verification of conformity with the SmPC.
  • Submission of the advertising approval dossier.
  • Consulting regarding the ethics of medical promotion.

Discuss with an Expert

Send us the details of your product. We will offer you a preliminary evaluation of the risk class and registration requirements.