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Provider profile

Syngene.

Bioanalytical services

Syngene describes bioanalytical laboratories for small molecules and biologics: ligand-binding and cell-based method development, validation and sample analysis for PK/TK, immunogenicity and biomarkers, and LC-MS/MS bioanalysis of small molecules and peptides, offered standalone or with BA/BE and Phase I–II studies, including antibodies, proteins and vaccines. Its corporate office is in Bangalore.

Website
syngeneintl.com (opens in a new tab)
Sources reviewed
November 4, 2026 · Source pages re-checked within 4 months
First published
November 3, 2026

This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.

Services and capabilities

Services and capabilities

  • Biomarker assays1,2
  • Cell-based assays1
  • Immunogenicity (ADA/NAb)1,2
  • Method development2
  • PK/TK bioanalysis1,2
  • Regulated study-sample analysis1

Platforms and methods

  • LC-MS/MS7
  • Ligand-binding assays1

Sample types

  • Dried blood spots and microsampling8
  • Plasma and serum8
  • Tissue8
  • Urine8

Development experience

Development experience

Development stage

  • Phase 12
  • Phase 22Stated for the small-molecule bioanalytical laboratory (clinical PK studies)
  • Preclinical2

Modality

  • Monoclonal antibodies1
  • Oligonucleotides7Described within discovery-stage DMPK services
  • Peptides7
  • Recombinant proteins1
  • Small molecules2
  • Vaccines1

Locations

Locations

  • Bangalore, India · Headquarters9Listed by the company as its Corporate Office

Quality and regulatory

Quality and regulatory

The provider’s own materials state that it works to, or holds, the following. ArgusBio has not inspected or audited these claims.

  • 21 CFR Part 111
  • GCP3Company-wide quality statement (GLP, GMP and GCP)
  • GLP1,3
  • GMP / cGMP4,5Stated for development, manufacturing and quality-control operations, not bioanalysis
  • ISO/IEC 270016Certificate listed for the Hyderabad site

Unknowns and questions to ask

Unknowns and questions to ask

Public sources rarely establish what matters most for a specific project. Confirm directly:

  • Whether a validated method already exists for your molecule or a close analogue, and who owns it
  • Validation scope against ICH M10 for your assay type, and expected timeline
  • Current instrument and analyst capacity, and turnaround per sample batch
  • Sample receipt, storage conditions, chain of custody and international shipping experience
  • Most recent regulatory inspection or audit outcomes relevant to your studies
  • Data-integrity controls and the format of data delivered to your PK or biometrics vendor

How to select a bioanalytical laboratory

Evidence and sources

Evidence and sources

  1. 1Advanced Bioanalytical Laboratory Solutions for Biologics (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  2. 2Laboratory Services | Clinical Development | Syngene (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  3. 3Quality Control And Management | Good Clinical Practices | Syngene CRO (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  4. 4Analytical Characterization & Quality Control for Biologics (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  5. 5Commercial Manufacturing - Syngene International Ltd (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  6. 6Quality & Regulatory Certifications - Syngene International Ltd (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  7. 7Biologics Analysis | ADME-DMPK Services at Syngene (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  8. 8Bioanalysis Quantitation | ADME-DMPK Services at Syngene (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
  9. 9Contact Us | Syngene CRDMO (opens in a new tab)Syngene · Provider website · retrieved November 3, 2026 · last checked November 3, 2026

“Last checked” means we confirmed the page was still available and still contained the cited statement. It does not mean ArgusBio verified the provider or its capabilities.

Something out of date or wrong? Request a correction. Corrections are reviewed against public sources before publication.

Contact

Contact

Contact the provider directly through its public contact page (opens in a new tab). ArgusBio does not forward inquiries to providers and does not receive referral fees.

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