Bioequivalence Studies

• Zi Diligence has built a brand of excellence in the conduct of bioequivalence and bioavailability studies with more than 250 studies to support generic drug registration.
• Taking into account reliable quality and credible data, Zi Diligence team is trained and empowered to deliver its very best each and every day. This attention to detail is supported by numerous successful regulatory inspections from Egyptian MOH, Gulf Cooperation Council (GCC), and SFDA.
• With our in-house scientific and regulatory expertise, proficient in all major drug markets, Zi Diligence can support the full study conduct from study design and protocol inception to the issuance of the final Clinical Study Report. All studies are conducted under strict adherence to GCP principles in accordance with EMEA, FDA and ICH guidelines.

With a strong profile of studies conducted on different formulations, Zi Diligence has also a massed scientific intelligence in the conduct of studies for:

• Different dosage forms for immediate and modified release.
• Oral dispersible, chewable and sublingual formulations.
• Inhalation products (Future planned).
• Suppositories.

Our team of PK Scientists, Clinical Operation specialists and Clinical Investigators work together to ensure the competent execution of BE studies that adhere to the Good Clinical Practice (GCP) principles that govern our industry. Supported by our Quality Control processes and governed by our Quality Assurance experts, we are committed to delivering excellence in clinical research with an unwavering commitment to service and client satisfaction.