Comprehensive bioequivalence services

from study design and protocol development to final reporting, backed by scientific and regulatory expertise.

A wide, bright corridor at NAMA Bio-Center running alongside the clinical ward, separated by a long band of internal observation windows, with a NAMA BIO roll-up banner at the far end.
The NAMA Bio-Center participant ward: rows of blue-and-white clinical beds in open, partitioned bays under bright ceiling lighting.

Bioequivalence Study Services

Protocol to clinical report, designed, dosed, sampled and monitored in our own unit.

  • Study design and conduct
  • End-to-end protocol development
  • Statistical planning
  • Supervised clinical conduct
Bioequivalence studies
The sample storage room at NAMA Bio-Center, with an ultra-low temperature freezer visible through an open sliding door and a clean preparation counter.

Bioanalytical Services

LC-MS/MS method development, validation and sample analysis to GLP, with Eurofins.

With Eurofins bioanalytical partner

  • LC-MS/MS method development and validation
  • Precise sample analysis
  • QC, documentation and traceability
  • SFDA-structured reporting
Bioanalytical services
The NAMA Bio-Center training room, arranged auditorium-style with rows of chairs facing two wall-mounted screens on a wood-panelled wall.

Training & Capacity Building

GCP, bioequivalence and regulatory training for sponsors, CROs and investigators.

  • Good Clinical Practice (GCP) training
  • Bioequivalence training
  • Regulatory & quality training
  • Customized institutional training
Training

Ready to partner with NAMA BIO-Center

Describe the molecule and the submission you are working toward. We will tell you what the study should look like — and what it does not need.