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GMP Testing Services
GMP & CMC Analytical Testing for Confident Pharmaceutical Development
Scientist-led analytical support for prescription pharmaceuticals, OTC drug products and drug–device combination products—from method development and raw material qualification through stability, release testing and complex investigations.
Quantum Analytics Group provides GMP and CMC analytical testing services that help pharmaceutical and biotechnology companies reduce risk, solve complex analytical challenges, and make confident development, manufacturing, and regulatory decisions. Our experienced scientists support programs from early development through commercial manufacturing with testing for APIs, drug products, and combination products, including method development and validation, stability studies, batch release, impurity investigations, and regulatory submissions. Using advanced analytical technologies and practical scientific expertise, we deliver accurate, defensible data that supports product quality, safety, and regulatory readiness.
As a trusted analytical partner, Quantum Analytics works directly with clients to develop efficient testing strategies that accelerate development while maintaining compliance with applicable FDA, ICH, USP, and EP expectations. Whether supporting Chemistry, Manufacturing and Controls (CMC) activities, troubleshooting manufacturing issues, validating analytical methods, or generating GMP analytical packages for regulatory submissions, our focus is on providing meaningful scientific insight, responsive collaboration, and reliable results that help move your program to the next milestone with confidence.
30+ Years
Supporting regulated industries with practical analytical expertise.
Real People. Real Answers
Work directly with scientits who guide, troubleshoot and explain - not just test.
FDA Registered & Inspected
GMP/GLP/QMS Compliant
ISO/IEC 17025:2017 Accredited
THE CHALLENGE
Every regulated product presents a unique analytical risk.
A raw material may not meet specifications. A method may not perform as expected in the actual product matrix. An unexpected peak may threaten a stability study or release decision. These situations require more than routine testing—they require scientists who understand what the result means and what to do next.
Development Risk
Methods must fit the product and lifecycle stage.
Develope, remediate and validate methods that are fit for purpose and generate meaningful information for the intended use.
Manufacturing Risk
Materials and processes can introduce variability.
Evaluate incoming materials, release requirements, unexpected results, and process-related concerns.
Regulatory Risk
Analytical data must support critical decisions.
Build strategies and documentation aligned with applicable FDA, ICH, USP and EP expectations.
Analytical strategies built around the product—not a standard workflow.
Quantum Analytics Group scientists consider fromulation, materials, manufacturing process, delivery system, regulatory pathways and lifecycle stage when selecting the appropriate analytical technique and method.
Prescription Pharmaceuticals
Analytical testing and support for APIs, clinical materials and commercial drug products
Tablets and capsules
Injectables and liquids
Topical dosage formsClinical and commercial products
OTC Drug Products
Testing and method support for over-the-counter medicines and consumer healthcare products.
Tablets and capsulesLIquid and oral solutions
Creams, gels and ointmentsn
Cleaning process development
Topical drug products
Combination Products
Analytical support for the drug, formulation, packaging interface and product-dpecific risks.
Prefilled syringesAutoinjectos and pens
Inhalation systems
Drug coated products
Medical Device Analytical Support
Advanced analytical support for device materials and investigations.
Material characterizationIdentification of unknowns
Contaminant invsetigations
Technical consultation
Faillure and chemical analysis
GMP analytical support across the CMC lifecycle.
From early stage method development through GMP testing and complex investigations, Quanum Analytics Group helps develope analytical methods and programs appropriate for the product and lifecycle stage.
Method Development & Optimization
Develop or improve methods for products, matrices and performance requirements.
Validation, Verification & Transfer
Establish and document method performance for the intended use .
Raw Materials & Excipients
Confirm Identity, purity, potency and suitability before materials affect manufacturing.
Drug Substances & Drug Products
Support characterization, specifications, release and quality decisions.
Residual Solvents
Routine and customized teting using Headspace GC-FID, Headspace GC-MS, and complementary methods..
Elemental Impurities
Risk based ICP-MS and ICP_OES techniques supporting USP<232>/<233>, ICH Q3D and Ph. Eur. 2.4.20
Stability & Release Support
Incoming material verification, batch consistency checks, production troubleshooting, and failure analysis.
Impurities, Unknowns & Contaminants
Investigation of degradation products, unexpected peaks, foreign materials, and trace contaminants.
START A CONVERSATION
What analytical decision does your team need to make?
Every analytical challenge is different. Begin with a confidential technical discussion to explore your objectives, analytical needs, and project timeline. If a more detailed review is appropriate, proprietary information can be shared under a mutually executed confidentiality agreement.
Monmouth Junction, NJ 08852
Corp & Admin Offices:
30 N Gould Street Suite 10683
Sheridan, WY 82801 USA