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Semler Group of Companies,
in business since 1946

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Inspections

FDA inspection

The inspection focused on the bio-equivalence study conducted for the product. FDA inspectors visited the facility to review study documents generated at our Clinical facility and Bioanalytical facility in Bangalore, India.

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WHO inspection

The inspection focused on the bio-equivalence study conducted for the product. The inspection covered all the sections of the GCP and GLP, including the WHO guidance for organizations performing in vivo bioequivalence studies. WHO inspectors visited the facility to review the study documents generated at our Clinical facility and Bioanalytical facility in Bangalore, India.

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EMA Inspection

The inspection focused on the bio-equivalence study conducted for the product. EMA inspectors visited the facility to review study documents generated at our Clinical facility and Bioanalytical facility in Bangalore, India.

MOH, Turkey and ISP MOH, Chile

Inspection was focused on the acceptance of the infrastructure available for the conduct of BA/BE study along with Standard operating procedures. Inspection involved Clinical facility and Bioanalytical facility in Bangalore, India.
The facility was accepted and certified for the conduct of BA/BE study.

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