Synergy Bioscience

Biocompatibility evaluation of medical devices including chemical toxicity, biological response, and physicochemical changes due to manufacturing processes, supporting regulatory submissions.

Custom-designed and compliant stability programs including protocol writing, sample definition, method development and validation, storage monitoring, data evaluation, and report writing for drug product approval.

Comprehensive biomarker analysis services for large molecules, small molecules, and Advanced Therapy Medicinal Products (ATMPs) supporting drug development with precise and actionable data.

Provides real-time and accelerated stability studies to evaluate product shelf life, storage conditions, and long-term regulatory compliance for pharmaceutical, biologic, and medical device development.

Tailored pharmaceutical and bio-pharmaceutical formulation development services for small chemical molecules and large protein molecules including enzymes, monoclonal antibodies, growth factors, complex glycoproteins, and novel recombinant constructs.

Evaluates physicochemical properties, degradation pathways, and excipient compatibility to identify the best formulation strategy; conducts stability studies under real-time and accelerated conditions to predict shelf life and ensure long-term product performance.

Precision analytical testing for industrial hemp and complex botanical extracts with DEA-licensed and ISO-certified laboratory oversight for global regulatory compliance.

Analytical chemistry services supporting pharmaceutical and biologic development through method development, validation, and advanced testing, designed to meet regulatory and scientific standards.

Development and FDA-approved commercial generic inhalation product combining inhaler and inhalation spray with optimized formulation, stability, content uniformity, and microbiological safety testing.

Testing service for terpenes such as Humulene, Limonene, Myrcene, Terpineol using Gas Chromatography-Mass Spectrometry (GC/MS) and Flame Ionization Detector (FID).

Validation service for final sterilizing filters and/or single-use assemblies including particle shedding study, binding study, extractables/patient safety/leachables assessment, chemical compatibility testing, bubble point/diffusion determination, and bacterial retention validation.

Testing service for heavy metals including Arsenic, Cadmium, Lead, Mercury using Inductively Coupled Plasma – Mass Spectrometry (ICP-MS).

Advanced elemental impurities testing services using validated analytical methods and state-of-the-art instrumentation to detect and quantify trace metals in pharmaceutical products, raw materials, and drug substances.

Development of a generic drug product for bacterial infections with optimized production process, lyophilization, stability testing, and dissolution profiling using HPLC technology.

A service by Synergy Bioscience offering detailed structural insights and accurate quantification of therapeutic proteins using Liquid Chromatography-Tandem Mass Spectrometry technology.

Validation service for prefiltration and bioburden reduction filters including bubble point and diffusion determination, extractables and patient safety assessment, and chemical compatibility testing.

Testing service for mycotoxins including Aflatoxin B1, B2, G1, G2, and Ochratoxin A using Liquid chromatography-mass spectrometry (LC-MS/MS).

Standardized testing to generate data predicting bioavailability, establish dosage form stability, and indicate manufacturing process changes, with method parameters adapted to dosage form and test objectives.

Expertise and state-of-the-art equipment for developing lyophilized/freeze dry preparations to meet product requirements.

Endotoxin testing services essential for patient safety in medical devices, injectables, and raw materials to detect endotoxins released from Gram-negative bacteria.

Consulting services for quality system compliance, regulatory submissions, and GMP quality management systems.

Consulting services for validation of equipment, processes, and systems used in medical device and pharmaceutical applications, including design validation, equipment qualification, software validation, cleaning validation, and more.

Integrated CRO services covering gene expression, molecular biology, protein production, cell-based assays, and multi-omics analysis for biologics development.

Provides advanced lyophilization (freeze-drying) support to improve stability for sensitive compounds; develops optimized cycles that protect product integrity and ensure reproducibility at scale; includes dissolution testing and drug release profiling to confirm performance and consistency.

Comprehensive microbiology testing complying with USP General Chapters for sterile and non-sterile products.

End-to-end development and pilot manufacturing for Antibody-Oligonucleotide Conjugates (AOCs), combining antibody engineering, linker design, oligonucleotide chemistry, and bioconjugation for small batches suitable for toxicology and early clinical studies.