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Science and labs

Accredited labs

We test how long a product stays good, whether its pack protects it on the road, and whether a batch is fit to sell. We give you reports you can file with a regulator.

What it is

In one sentence

We run lab tests on your product and its packaging, to the standards your regulator expects.

Who it is for

Quality and regulatory heads at pharma, medtech, nutraceutical and FMCG companies who need stability, packaging, transport or batch release testing.

Problems it solves

What goes wrong in testing, and how we prevent it

  • Cold chain never tested on real routes

    Many shipping tests use ideal conditions. This is a common gap at inspection. We test against the real heat, humidity and height of the places your product travels.

  • Too much retesting after a packaging change

    A new pack does not always mean a full new stability study. We first check what your existing data already covers. Then we test only the gap.

  • Results spread across many labs

    When tests are split across labs, the results are hard to bring together for one release decision. We plan the tests together and give you one set of results.

What you get

Deliverables

  • Stability studies at ICH conditions: long-term, intermediate, accelerated and light exposure
  • Packaging validation
  • Transport validation, including cold chain studies with temperature loggers
  • Method development and validation to ICH Q2(R2)
  • Checks and transfer of pharmacopoeia methods (USP, EP, IP and JP)
  • Batch release testing, with a certificate of analysis (the signed report of a batch's test results)
  • Label checks
  • A packaging change impact assessment, before any new testing
  • Biocompatibility testing to ISO 10993, with partner labs where needed

How it works

How a testing project runs

Routine batch release testing typically takes 5 to 10 working days from sample receipt.

  1. Agree the plan

    We confirm what must be tested, which method to use and which standard applies. You get a written test plan.

  2. Receive the samples

    We log each sample on arrival and check its condition. We keep a record of who handled it, from receipt to report.

  3. Test

    We run the tests to the agreed method. For stability, we pull samples at each agreed time point.

  4. Review and report

    A second person checks the results. You get a signed report, ready to file.

Regulators and standards

Standards we test to

ISO/IEC 17025
The international standard for testing labs. It shows that a lab's results can be trusted. Our certificate: No. UK-02-VS-04215, renewed every year.
ICH Q1A(R2) and Q1B
International guidelines for stability testing. They set the temperature, humidity and light conditions.
ICH Q2(R2)
The international guideline for proving that a test method works.
USP, EP, IP and JP
The United States, European, Indian and Japanese pharmacopoeias: official books of test methods and quality limits for medicines.
ISO 10993
The international standard for biocompatibility: whether a device's materials are safe in contact with the body.
Terms explained
Stability study: storing a product under set conditions and testing it over time, to set its shelf life. Batch release: the tests a batch must pass before it can be sold. Method validation: proving a test gives correct results, again and again. Transport validation: proving a product stays within its limits during shipping.

Proof

Our lab holds ISO/IEC 17025 (Certificate No. UK-02-VS-04215). We also hold ISO 9001:2015 (Certificate No. 24ZAAO0753Q).

FAQs

Questions we are often asked

Which accreditation do your labs hold?

ISO/IEC 17025, the international standard for testing labs. Certificate No. UK-02-VS-04215. It is renewed every year. We share the certificate and its scope on request.

Can you run USP, EP, IP or JP methods?

Yes. We check that pharmacopoeia methods work in our lab for your product. We also take over methods from your lab or another lab, which is called method transfer.

Do you develop and validate test methods?

Yes. We develop methods and validate them to ICH Q2(R2). This shows the method is accurate, gives the same result each time, and still works when small things change.

Which stability conditions do you offer?

Long-term, intermediate, accelerated and light exposure (photostability) conditions, as set out in the ICH guidelines.

How long does a routine batch release take?

Typically 5 to 10 working days from when we receive the samples. Faster slots are possible if you plan with us in advance.

Can you do both microbiology and chemical tests for batch release?

Yes. We plan both together, so you get one set of results and one contact. Chemical tests include assay (how much active ingredient is present), related substances, pH, viscosity, heavy metals and elemental impurities. For microbiology tests, see Microbiology studies.

Our product must stay cold while it is shipped across India. How do we prove the cold chain holds?

With a transport validation study. We design worst-case shipments, such as summer heat in Rajasthan, monsoon humidity in Kerala and high routes in the Northeast. We put calibrated temperature loggers in the shipments. We compare the readings with your product's stability data. The report shows your cold chain works on your real routes, not only in ideal conditions.

Do you support ISO 10993 biocompatibility testing for medical devices?

Yes. We plan the biological evaluation under ISO 10993-1. Tests such as cytotoxicity (harm to cells), sensitisation (allergy) and irritation run mostly with our partner labs. We manage the study design, samples, lab work and data review. You get one biological evaluation report.

Our product is approved, but we are changing the packaging material. Do we need to repeat all stability testing?

Usually not all of it. A packaging change almost always needs some testing. How much depends on how the new material differs: how well it keeps out moisture and air, what may leach into the product, and how it reacts with the product. We first compare your existing data with the new material. Often a short study comparing the old and new packs is enough. We tell you what is needed, and what is not.

These answers are general information, not advice for your product. Rules change. Check the latest guidance, or ask our team about your product.

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Start a conversation

Talk to a lab lead.

Tell us about your product and what you need to test. We will suggest the tests, the standard and a timeline.

Tell us about your product → Or call +91 88671 25414