Clinical trials

Submissions and approvals receiving from Central Ethics Committee (CEC) and State Agency of Medicines (SAM).

We ensure the professional preparation and submission of all necessary documentation, including the adoption of Patient informed consent form according to the legislation of the Republic of Latvia. Experienced professionals ensure fast and professional communication with responsible institutions in order to set optimal and predictable project timelines.

Clinical trial feasibility – project “Feasibility”.

Our company holds an extensive client’s data base that allows the performing of a qualitative test of a clinical trial’s feasibility to evaluate the potential of the planned trial and performance in various fields of medicine (intern medicine, endocrinology, psychiatry, oncology, etc.).

Monitoring of clinical trials phase II-IV in accordance with ICH-GCP requirements.

An experienced monitor will perform the monitoring of the clinical trial according to all requirements of good clinical practice.

Regulatory affairs

FMS Baltic goal is to assist Pharmaceutical, Biotechnology, and Medical Device and Nutraceutical companies to achieve optimal time-to-market of their pipeline products.

We are continuously scanning the environment in Latvia ,Lithuania, Estonia, Russia, Ukraine and Belarus to identify internal and external forces driving specific areas of drug, biologic and medical device registrations in the area. This includes monitoring regulatory policies and requirements, review performance, agency initiatives, and reimbursement trends that can affect clients`s business.

We offer:

  • Strategic Planning
  • New Drug Application/Submission NP,DCP,MRP
  • Food Supplements registration
  • Variation Submissions
  • SmPC, PIL, Labeling translations
  • Licenses, Patents
  • Pharmacoeconomic studies, Reimbursement Applications
  • Leaflet User testing
  • Common Baltic package development
  • Pharmacovigilance
  • Post-marketing compliance and maintenance
  • Training, SOP training

Legal advice

Management of FMS Baltic has experience in legal issues such as:

  • pharmaceutical law
  • patent registration, patent infringements issues
  • registration of merchants in the Commercial Register, amendments
  • labor law
  • appealing of audit opinions and other decisions of the State Revenue Service (including in customs and administrative cases), Pharmaceutical Inspectorate client’s interests‘ representation in state, municipal and court establishments

Pharmaceutical and food supplement marketing

Management of FMS Baltic has 15 years of experience of pharmaceutical marketing. Pharmaceutical marketing is done thorough our sister company Farma mārketinga serviss Ltd. The areas of expertise are:

  • Review of products and portfolios
  • Analysis of market potential of reviewed products in Baltic States
  • Objective advice on advertising and promotion strategy
  • Contacts with wholesalers and Key Opinion leaders
  • Staff recruiting, hiring, outsourcing.

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