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BA/BE SERVICES

  • Bioavailability & Bioequivalence studies
  • Drug-Drug interactions
  • Steady state
  • Dose response
  • Food effect
  • Partial / full replicate-design studies
  • In-Vitro & In-Vivo correlation (IVIVC) Studies
  • Blinded studies
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CLINICAL TRIALS SERVICES

Quantys is capable of undertaking Phase I & Phase II Clinical trails with the following services:

  • Investigator and site selection
  • Site initiation and management
  • Regulatory and ethics approval
  • Safety Reporting
  • Study Monitoring and Project Management
  • Audit and compliance
  • Data Management
  • Statistical Analysis and Report Preparation
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BIOANALYTICAL SERVICES

The BA services are an integral part of Quantys and offers the following services in various biological matrices:

  • Method development & validation of complex drugs & metabolites assay
  • Analysis of parent compounds and it’s metabolites in various biological matrices
  • Custom assay development for pre-clinical samples
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QUALITY ASSURANCE (QA):

  • The team is committed to ensuring strict compliance to regulatory standards and dedication to high quality, accurate results which in turn facilitate swift and successful approval of sponsor projects.
  • Quality Assurance is responsible for ensuring that all projects are conducted in compliance with the study protocol, Operating Procedures and Regulatory & ethical guidelines.
  • The QA ensures strict compliance to GCP, GLP and other regulatory requirements.
  • QA ensures compliance by using validated systems and software’s in line with 21 CFR PART 11
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INDEPENDENT & STANDALONE SERVICES:

Besides Quantys integrated services, we also offer the following independent services such as:

  • Protocol design
  • Sample size estimation and justification
  • PK modelling & analysis using WinNonLin
  • Randomization & Statistical analysis using SAS
  • Report preparation in E3 and eCTD formats
  • Regulatory Dossier preparation
  • Post submission query support
  • Trial monitoring
  • Document archival
  • R&D services & contract manufacturing of clinical trial batches of various finished dosage formulations.

    • We have a dedicated and experienced team which is crucial for a success of various regulatory submissions of products