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Pharmaceutical Analytical Services

Analytical Testing For Pharmaceutical Development and Manufacturing

Quantum Analytics Group helps pharmaceutical and biotechnology companies reduce technical and regulatory risk through scientist-led GMP analytical testing and CMC support. From early development through commercial manufacturing, we provide accurate, defensible analytical data that supports confident product, quality, and regulatory decisions. 

30+ Years
Supporting Regulated Industries
FDA Registered & Inspected
Quality focused laboratory support
QMP/GLP/QMS
Compliant Analytical Lab Operations
ISO/IEC 17025:2017 
Accredited Laboratory
Analytical Development
Develope, optimize, validate, transfer methods
Drug Product Testing
API, finished products, stability and release 
Raw Materials
Identity, purity, potency, and compendial suppot
Impurities & Investigations
Contaminants and unknowns, degradation products
ANALYTICAL CONTINUITY ACROSS THE PRODUCT LIFECYCLE

One scientific partner for the decisions that move a product forward

Analytical needs change as a pharmaceutical program advances. Early development requires characterization and method strategy. Manufacturing requires reliable material and product testing. Release and regulatory milestones require defensible data and documentation. Commercial products require ongoing support when methods, processes or results change.

Quantum Analytics Group works directly with pharmaceutical and biotechnology teams across these stages, providing practical analytical strategies, responsive technical support and clear scientific communication - supporting development, manufacturing, release and lifecycle decisions.conference

 

 

Development Risk

Develop, optimize or remediate methods that are fit for the product, matrix and lifecycle stage.

Manufacturing risk

Evaluate incoming materials, batch consistency, unexpected results and process-related concerns.

Release and regulatory risk

Generate reliable analytical data and documentation for quality decisions, batch disposition and applicable regulatory expectations.

Lifecycle risk

Support method changes, process investigations, supplier changes, unexpected results and continued product-quality decisions.

ANALYTICAL DEVELOPMENT

Build analytical methods that remain useful as the program advances.

Quantum supports analytical programs where a method must be created, optimized, validated, transferred or remediated for use in development, manufacturing, release or ongoing product support.

Rather than treating method development as an isolated laboratory exercise, our scientists consider formulation complexity, expected impurities, required sensitivity, compendial context, lifecycle stage and the intended quality or regulatory use of the data.

 

FIND OUT MORE ABOUT OUR GMP & CMC SERVICES

7-1Define The Analytical Target

Clarify analytes, product matrix, specifications, sensitivity, selectivity and the decision the method must support.

8-1Develop Or Optimize

Select appropriate techniques and conditions, evaluate interferences and improve performance for routine use.

9-1Demonstrate Suitability

 Support qualification, verification or validation based on intended use and applicable requirements.

 

10Transfer And Troubleshoot

Support method transfer, investigate performance gaps and remediate methods that are not working as intended.

 

PRODUCT-FOCUSED ANALYTICAL STRATEGIES

Support Organized Around the Material or Product Your Team Must Understand

Our scientists consider the product matrix, materials, manufacturing process, regulatory pathway and lifecycle stage before selecting the analytical approach.

APIs, Raw Materials & Excipients

Identity, purity, potency, suitability and compendial support before materials affect development or manufacturing.

 

Rx & OTC Drug Products

Analytical development and testing for finished dosage forms across development and commercial quality activities.

Combination Products

Analytical support for the drug, formulation, packaging interface and product-specific risks.

 

Medical Device Support

Advanced analytical support for device materials, unknowns and technical investigations.

ACROSS THE PHARMACEUTICAL LIFECYCLE

Analytical Support from Early Development Through Release and Lifecycle Management.

Quantum can support individual analytical activities or provide continuity as a program advances. Project scope is tailored to the product, stage, regulatory objective and quality-system requirements.

SPEAK WITH ONE OF OUR PHD SCIENTISTS

01 - Discover

Early Development

Define analytical risks, characterize materials and establish a practical testing strategy.

 

02 - Develop

Methods & Product Knowledge

Develop or optimize methods and build understanding of the product, matrix and impurities. 

03 -  Establish

Validation & Transfer

Demonstrate method suitability and support verification, validation or transfer activities.

 

04 - Support

Manufacturing & Scale-Up

Support raw-material, in-process, product and investigation needs as manufacturing programs advance.

05 - Release

Stability, Batch & Regulatory Milestones

Develop or optimize methods and build understanding of the product, matrix and impurities.

 

06 -  Sustain

Commercial Lifecycle Management

Address method changes, supplier or process changes, unexpected results and post-approval analytical needs.

 

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.

 

REQUEST A QUOTE

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 

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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.

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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. 

Address:
11 Deerpark Drive, Suite 104

Monmouth Junction, NJ 08852

Corp & Admin Offices:

30 N Gould Street Suite 10683
Sheridan, WY 82801 USA

 

Call: (800) 448-2968

Email: info@quananalytics.com