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
- Urinary retention
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
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:
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
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