Bioequivalence Studies
At Fusion Trading, every product is developed to match the innovator brand with uncompromising accuracy. We employ some of the most rigorous testing methods worldwide, including bioequivalence (BE) studies that directly compare our formulations with the reference product.
Our bioequivalence team oversees the entire process — from protocol development to clinical trial execution and regulatory submissions — ensuring global standards of quality and compliance.
World-Class Expertise
We take pride in our highly skilled professionals, trained to international standards in clinical research. Their expertise ensures that every study conducted meets stringent scientific and regulatory expectations.
Clinical Operations Department
Our state-of-the-art clinical facility, covering 4,500+ sq. m., can accommodate 150+ subjects at a time. The team manages all aspects of clinical trials, including:
- Recruiting and counseling volunteers
- Screening and summarizing data
- Ensuring medical follow-ups for abnormal results
- Safety monitoring and adverse event reporting
- Protocol and study design creation
- Ethics committee submissions (protocols, CRFs, ICFs)
- Comprehensive trial report preparation
Bioanalytical Laboratory Team
Our bioanalytical experts conduct high-precision assays for drugs and metabolites in pharmacokinetic studies. With proven expertise in protein precipitation, liquid-liquid extraction, solid phase extraction, and derivatization techniques, they deliver validated and reliable results ahead of industry demands.
Pharmacokinetics Team
This team specializes in study design and bio-study protocol development, ensuring the right scientific approach for each molecule. Their expertise covers:
- Multiple dose studies
- Parallel design studies
- Reference replicated designs
- PK/PD studies