Clinical trials and other CRO services in Bulgaria

Farmavita.Net member offers CRO services. Member is a Bulgarian Contract Research Organization which provides high quality support services to the pharmaceutical industry.

The domain of their experience and activities includes:

 1. Registration and marketing

Well-established collaboration with the experts from Bulgarian Drug Agency contributes to the easy and trouble-free registration. Thus they assist the costumers to be well oriented in the dynamic regulatory environment.

2. Analytical services – development and validation of HPLC methods

• Active substances and their impurities in finished dosage forms
• Drugs/ metabolites in biological samples

3. Clinical Trials

·         Project Management
·         Monitoring
·         Preparation of clinical trial documentation (CTP, IB, CRF, ICF)
·         Insurances, Regulatory Services
·         Drugs logistic
·         Biological samples logistic
·         Data Management
·         Statistical Analysis
·         Preparation of Integrated Study Report
·         Archiving 

All services are carried out in accordance with ICH Good Clinical Practice guidelines.

The company proved high quality of work with good results from sponsor-audits, GCP inspections in Bulgaria and in Romania.  Since founded in 1998, company has managed over 30 clinical trials (Phase I - IV).  

The company has long successful experience in the following areas:

• Oncology
• Onco-haematology
• Neurology
• Cardiology
• Metabolic disorders
• Pharmacokinetics (bioavailability and bioequivalence)

4. Contracting of high-qualified CRAs

The good responses from the multinational companies prove that their monitors know in details the GCP principles but also they can work in team.   

Their customers are Sopharma, Servier Laboratories, Pfizer, Jonhson & Jonhson, Ribosepharm, Lyomark, etc. 

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