Partner with us

Why Partner with Synergy Bioscience for your Product Development and Testing?

Synergy Bioscience is not just another CRO. We combine years of expertise and deep understanding in the life science sector, helping your organization benefit from our advanced capabilities. Our commitment to quality, speed, and a very competitive cost is what sets us apart.

Our Core Competencies

Product Development
  • Biosimilars monoclonal antibodies development
  • Structural chemistry (using Orbitrap LC-MS/MS)
  • Chemical and biological therapeutics pre-formulation and formulation
  • DNA amplification and sequencing
  • Generic drug product reengineering and development
  • Dissolution studies (bioavailability/bioequivalence)
  • Lyophilization (freeze-dry)
  • Cell line and vaccine development
  • Extractables/leachables
  • Product shelf-life determination
Microbiology Testing
  • Sterility testing
  • Endotoxin testing
  • Antimicrobial effectiveness testing
  • Antibiotic potency testing
  • Particulate matter testing
  • Environmental monitoring testing
  • Microbial Enumeration testing
  • Medical Devices bioburden testing
Quality Compliance Consulting Support
  • Validation studies
  • CMC section support
  • FDA-inspection remediation support
  • Quality system gap assessment and development
  • cGMP auditing & training
  • Supplier quality auditing
  • CAPA investigations
Analytical Chemistry
  • Analytical development and validation
  • Therapeutic protein analysis and characterization
  • Chemical structure determination
  • Extractable/Leachable testing
  • Elemental impurities (trace metals)
  • Residual solvents
  • Biocompatibility
  • Bioavailability/Bioequivalence testing
  • Container closure integrity testing

What Makes Us Different

Standards & Compliance:
  • Expertise with cGMPs, SOPs, audits, traceability
  • Compliance of our Quality System with USP/NF, 21 CFR – Part 3 & 4 & 11 & 210 & 211, 600s, ICH, A2LA & ISO 17025, and AOAC
  • Full compliance with stringent Internal Audit Program
  • Timely completion of OOS Investigation/Corrective Action Documentation
  • 100% Compliance Auditing outcomes.
  • All Equipment – IQ/OQ/PQ & Calibration & Maintenance Tracking Systems
  • CFR 21 Part 11 Compliant (Data Integrity)
  • Dedication to Employee Training (cGMP, Company & Client SOP’s, Safety, Documentation, SOPs, new technologies)
  • Experienced in consultation, validation, and quality compliance matters.
  • Final review of results by QA ensures accuracy and completeness of reports
  • Quality Submission Documentation
  • FDA Registered
  • DEA Registered
  • ISO 10993 Certified
  • A2LA Accredited
  • ISO 17025 – 2017 Certified
  • GMP Compliance Inspection
  • Inspection Results: No 483s or Warning Letter received!
  • Complete recommendation for approval as a cGMP compliant contract testing facility
Our Philosophy:
  • The most basic principle underlying the relationship between a life science company and a CRO is driven by the Golden Triangle of quality, speed, and cost.
  • We can swiftly adapt to shift triad weightings during the development timeline.
    • Early in the candidate development, timing is prioritized over cost.
    • As the candidate progresses, cost becomes a more significant factor, but quality remains paramount.
  • Our commitment to understanding our partners, adapting our role accordingly, and ensuring lasting relationships positions us as “preferred suppliers.”

Our Guarantee

Not only do we promise top-tier services, but we also offer rapid Turn Around Time at unmatched competitive pricing. Additionally, we provide continued technical support throughout our partnership.

Get in Touch

Our team is keen to understand your product/project requirements and provide tailored solutions to guarantee your success. Reach out to explore how Synergy Bioscience can be your strategic ally.