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An experienced partner to help you navigate your biopharmaceutical research & development

Differentiators

1

Experience

Team has three decades of experience in handling BA/BE studies for various global markets

2

Regulatory Inspections

Team has experience in handling more than 50 global regulatory audits

3

Partnership

Leveraging our team & infrastructure to partnering up with client development activities

4

Global presence

Tie up with various global CROs to execute the study within interested geographic region

5

Automation

Automation (online) of activities from Screening to selection of subjects, EDC & Analytical activities

In a Nutshell

Our Services

Clinical Services

  • Single and multiple dose studies
  • Long housing/duration studies (housing period >15days)
  • Studies required to draw multiple blood sampling and keep long washout period and continues monitoring
  • Studies on special population
  • Patient based BE studies
  • Hospital set-up BE studies
  • PK studies/Proof of concept studies
  • 505 (b)2 submission studies & NCE-1 studies
  • Studies on special formulations (Lozenges, Injections, Skin patches, Suppositories, Sublingual, Oral films etc…)

Bioanalytical Services

  • Our state-of-the art analytical facility equipped with advanced LC-MS/MS systems and automated samplers
  • LIMS to streamline and automate the analytical activities
  • Large molecule estimation by using ELISA
  • Stand alone Bioanalytical works (Accommodate the sample analysis in a quick turn around time)

Pharmacokinetic, Biostatistics & Data Management

  • Standalone PK & Stat analysis
  • Insights on formulation development based on the pilot data
  • Statistical inputs in study protocols
  • Population BA/BE studies
  • CDISC (SDTM) datasets

ADVITY RESEARCH PRIVATE LIMITED

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© 2022 Advity Research, All Rights Reserved.