pharm-ADVICE | Services

Pharmacoeconomy

We prepare documentation for applying the medicines on the positive list (A list) of government funds in Serbia, Montenegro and other countries in the region in accordance with their regulations.

For that purpose we:

Add pharmacoeconomic parts in clinical studies
Conduct all types of pharmacoeconomic analysis
Write expert reports

Registration of Drugs

Within the scope of consulting services and preparation of documents in the field of placing drugs on the market we perform following services:

Creating a registration dossier to the EU and the CTD format
Making expert preclinical reports
Making expert clinical reports
Making expert report on the pharmaceutical chemical and biological documentation
Preparation of expert reports on pharmacological and toxicological documentation
Making PSUR (Periodic safety update report)
Creating SPC's (Summary of product characteristics) and PIL (Instructions for the patient)
Making amendments or renewals of existing registration dossiers to the EU format

At your request we follow the course of registration until obtaining authorization for medical products and devices on the market.

Clinical Trials

Experts employed in Pharm-advice have years of experience in the field of preparation of documentation for clinical trials, in the organization, implementation and monitoring of clinical trials from phase I to IV, according to the principles of GCP.

This area includes:

Preparation of documentation for clinical trials, development of protocols, preparation of documentation for ethical committees, information on respondents and writing the final report of a clinical trial
Preparation of documents, organization of the bioequivalence study and writing of the final report
Organizing verification of information respondents to Your request
Organizing, monitoring and conducting pharmacovigilance, with the development of protocols and report writing

At your request following the course of registration to obtain authorization for medicinal products and medical devices on the market.

Translations

We translate professional medical documentation relating to:

Registration of medicines and medical devices
Clinical trials
Information for respondents

Statistical Reports

Development of statistical reports in the area:

Preclinical and clinical studies
Doctorate and master degree
Pharmacoeconomic trials

Consulting services and manufacturing software solutions within the healthcare information systems in the field of medicines, medical devices, primary health care, hospital information systems.

We are writing Standard Operating Procedures (SOP)-s to Your request, in particular areas as agreed.

Useful Links

http://www.alims.gov.rs/
The Agency for Medicines and Medical Devices in Serbia
http://www.rfzo.rs/
Republic Fund for Health Insurance of Serbia
http://www.fda.gov/
The US Food and Drug Administration
http://www.ema.europa.eu/ema/
The European Agency for Drugs
http://www.ispor.org/
International Society for Pharmacoeconomics
and Outcomes Research