Analytical & Stability Testing

At Envisage, we help life sciences, biotech, and pharmaceutical companies ensure that their products are safe, effective, and compliant with global regulatory standards.

Our Analytical and Stability Testing services combine deep scientific expertise with industry best practices, enabling organizations to accelerate R&D, streamline quality control, and safeguard product integrity.

Analytical Testing involves examining the chemical, physical, and biological characteristics of a sample to determine its identity, purity, potency, and quality.

Stability Testing assesses how a product’s safety, efficacy, and performance hold up over time under different environmental conditions such as temperature, humidity, and light exposure. Together, these services provide the scientific foundation for product development, regulatory approval, and market readiness.

Key Use Cases

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Research &
Design

Supporting early-stage drug and device development by identifying impurities, contaminants, and degradation pathways to guide formulation design.

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Quality Control in
Pharmaceuticals

Ensuring GMP compliance by validating that each batch of drug products consistently meets identity, potency, and safety standards.

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Materials
Characterization

Analyzing polymers, biomaterials, and excipients to understand their performance and stability across different applications.

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Defect &
Contamination Testing

Detecting impurities, foreign particles, and contaminants that could compromise safety, reliability, or shelf life.

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Environmental
Testing

Studying the impact of temperature, humidity, and storage conditions on the quality and stability of pharmaceuticals, biologics, and medical devices.

Solutions Delivered

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Analytical Testing for Pharma Startup

Worked closely with a Natick-based pharmaceutical startup on analytical testing of multiple drug products. Our focus was on identifying impurities, contaminants, and degradation, providing critical insights to accelerate R&D and strengthen regulatory compliance.

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Biopolymer Identification & Optimization for Biotech Firm

Partnered with a Boston-based biotech company to lead identification, production, and optimization of biopolymers and alginates. Our involvement spanned all stages — from concept to production — ensuring the biomaterials were stable, scalable, and compliant for commercial use.

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Testing & Validation for Diagnostic Devices

Engaged with a global medical device firm to conduct testing and validation efforts (hardware and software) on diagnostic equipment. We ensured the devices met safety, reliability, and regulatory requirements, strengthening the company’s go-to-market strategy.

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Stability & Specification Support for RNA Drug Products

Engaged by a global pharmaceutical firm to provide stability and specification testing for RNA drug products in a GMP environment. The scope included analytical testing, data review, authoring SOPs, and supporting regulatory submissions, ensuring alignment with FDA and international standards.

Next Steps to Kickstart Your Project Today

Connect Us

Let’s Connect

Reach out to us via the contact form to get started. We’ll then share an NDA for completion, after which you can select a convenient time and schedule a Zoom session with our expert team.

Explore Your Idea

Discuss your vision with our specialists to assess technical feasibility and potential for successful implementation.

Receive Your Proposal

We will create a detailed proposal tailored to your specific needs.

Launch the Project

With the agreement in place, we assemble the right team to initiate and drive your project to completion.

FAQs

What is the difference between Analytical Testing and Stability Testing?
Analytical Testing determines a product’s identity, purity, and potency, while Stability Testing evaluates how its quality and performance change over time under varying conditions.
Can Envisage support GMP-compliant testing?
Yes. We have extensive experience providing analytical and stability testing within GMP environments, ensuring full compliance with FDA and global regulatory standards.
Do you work with startups as well as large enterprises?
Absolutely. We partner with both early-stage biotech startups and global pharmaceutical leaders, providing flexible engagement models tailored to each client’s needs.
What industries do you serve?
We work across pharmaceuticals, biotechnology, and medical devices, supporting analytical and stability testing from R&D through commercialization.
Can Envisage also provide staffing for quality and testing functions?
Yes. In addition to project-based solutions, we also provide specialized talent in analytical chemistry, validation, QA/QC, and regulatory compliance.