Nearly Two Decades of Trial Experience

So Your Trial Can Run Efficiently & Effectively

  • Staffed office since 1998
  • Country Manager is an MD with nearly 20 years dedicated service to Pharm-Olam
  • Staff includes a toxicologist and General physicians
  • FDA/EMA approvals include trials in:
    • Acute Bacterial Skin and Skin Structure infection (ABSSSi)
    • Crohn’s disease
    • Pulmonary hypertension
    • Tinea pedis
    • Schizophrenia
    • Urinary retention

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Bulgaria Map

 

 

 

Predictable Regulatory Framework and Timelines


Predictable Regulatory Framework and Timelines

Standardized regulatory processes mean minimal compliance headaches.

  • In 2007, Bulgaria passed the Medicinal Products in Human Medicine Act, formally adopting EU directives and requirements
  • Submit to Ethics Committee and Regulatory Authority (Bulgarian Drug Agency) simultaneously, streamlining your application flow
  • Shortened approval timeline: 60 days (1990s: 90 days)

 

 

 

Concentrated, Disease-Diverse Patient Population

Concentrated, Disease-Diverse Patient Population

Patients face many types of health issues and are local to treatment centers.

  • Urban population is 73.9% of total population (7.2 million) as of 2015
  • Diverse pathology areas:
    • Cardiology
    • Endocrinology
    • Gastroenterology
    • Oncology
    • Psychiatry
    • Respiratory
    • Rheumatology

       
Robust Medical Infrastructure

Robust Medical Infrastructure

Resources, readiness for clinical trial challenges set Bulgaria apart.

  • Good medical infrastructure, supported by tax revenue and National Health Insurance Fund (NHIF)
  • Select your site(s) from over 200 institutions, including university hospitals, pathology-specialized hospitals and outpatient clinics
  • More hospital beds per capita than United States
  • Hotspot for Phase III studies
What Our Clients Say

What Our Clients Say

Timelines achieved and open communication

"Turnaround timelines for actions were consistently achieved and Pharm-Olam's constant communication with the global teams and vendors resulted in a smooth execution of study and on-site activities."

- Associate Director, Clinical Operations

 

See why working with Pharm-Olam in Bulgaria could be the best choice for your next study.


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