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Part of US based
Semler Group of Companies,
in business since 1946

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Service Overview

"We are experts in conducting studies for local and international regulatory submissions and have the necessary infrastructure to support our proficiency. With unparalleled method development and validation processes and access to vast volunteer pools, early phase studies at Semler Research Center are poised to take a quantum leap."- Umesh B A, Vice President, Corporate Development.

Semler Research Center (SRC) offers two state-of-the art pharmacology centers in India to conduct early phase pharmacological and drug developmental studies. We leverage the team's combined experience of over 50 years in conducting over 750 drug studies ranging in size from 40-400 volunteers in various therapeutic areas for various regulatory submissions. SRC serves the bio-pharmaceutical market by conducting quality bioavailability & bioequivalence studies both economically and efficiently.

Our services are end-to-end and customized to meet each client's specific requirements. The studies are ably supported by our bio-analytical team with in-depth expertise in generating methods that are accurate, precise, selective, sensitive and reproducible. Our proficiency is constantly upgraded to meet evolving requirements for various approvals, including novel therapeutic drugs, generic drugs and post–approval formulation changes. We have over 200 methods readily available. The bioanalytical team also supports complex pharmacokinetic studies in patients conducted by the clinical development team for early exploratory, investigative or screening studies which support regulatory submissions

Key Differentiators:

Regulatory Expertise:

  • On time project delivery
  • Strong method development expertise
  • Strong commitment to GLP compliance
  • Exceptional technical expertise
  • Expertise in separation technology
  • Dedication to customer service
  • Focused on method robustness and ruggedness
  • GLP compliant systems for bioanalytical sample analysis
  • Outstanding PK data analysis and reporting capabilities
  • US FDA
  • Health Canada
  • EMA
  • MHRA
  • WHO
  • TCA
  • MoH Chile
  • MoH Turkey
  • NPCB
  • Others
 

WHO PIR Audit Reports for Semler Research Center (View)

Local regulatory approvals (View)

DCGI Approval (View)