Analytical Method Development & Validation

Get methods that measure what you claim, reliably, and stand up to a regulatory or customer audit.

How Analytical Method Development & Validation works

1Assessment of requirement
2Sample collection
3Right lab assigned
4Testing
5Test report

Trusted by Leading Brands Across the Globe

Overview of Analytical Method Development & Validation

Tested by: NABL-accredited partner lab
Regulation: ICH Q2(R2) & Q14
Typical turnaround: 3–6 weeks
Sample needed: Product, placebo and standards

A result is only as good as the method behind it. ICH Q2(R2) sets out how to validate analytical procedures, and ICH Q14 how to develop them, with the method’s intended purpose defined up front. Regulators expect validated methods for assay, impurities and dissolution in every dossier, and buyers of nutraceuticals increasingly ask for validated methods for active content.

Validation shows specificity, linearity and range, accuracy, precision, detection and quantitation limits, and robustness. Pharmacopoeial methods need only verification that they work for your product in the lab using them. When a product moves between sites or labs, a method transfer study confirms both get the same results.

What we do for you

Lab and parameter list chosen for your purpose: licence, export, buyer or internal QC
Sampling guidance, and pickup or on-site sampling where needed
One contact who follows up with the lab until the report is issued
Report explained in plain language, with next steps if a result fails

What to send

The lab confirms the exact quantity and packing for your product when we book the test.

Sample

Quantity: Product, placebo and standards
Sealed and labelled with the product name, batch number and date
Packed so that it cannot leak or be contaminated in transit

Details to share

Product name, composition and licence category (AYUSH, CDSCO or FSSAI)
Label and claims
The pharmacopoeia, standard or buyer specification to test against
Purpose: licence, tender, export or internal QC

How we handle Analytical Method Development & Validation

1
Assessment of requirement
We confirm the standard, the list of tests and how many samples your product needs.
2
Sample collection
We collect the samples from your factory or warehouse, or tell you exactly where to send them.
3
Right lab assigned
We choose an accredited lab (NABL, BIS-recognised or ILAC) that covers your standard and can start soonest.
4
Testing
The lab tests your samples against the standard. We follow up and tell you at once if a test fails.
5
Test report
You receive the signed test report, ready to use for BIS, WPC, CE or your buyer.

What the lab tests

Parameter	Why it is checked
Specificity	Measures only the intended analyte
Linearity and range	Response across concentrations
Accuracy and precision	Recovery, repeatability, intermediate precision
LOD and LOQ	Impurity and trace methods
Robustness and solution stability	Small changes in conditions
Method transfer and verification	New site or pharmacopoeial method

The final list depends on your product, its standard and the purpose of testing. We confirm it with you before the sample goes to the lab.

Frequently asked questions

Do we need to validate a pharmacopoeia method?

No, but you must verify that it works for your product, matrix and lab. Verification is shorter than full validation and usually checks specificity, precision and accuracy.

Will regulators and buyers accept the report?

Testing is done in NABL-accredited labs, and where a licence requires it, in labs approved under the Drugs and Cosmetics Rules. We confirm the requirement for your licence, tender or buyer before testing.

Who carries out the testing?

Instacertify’s partner laboratories, accredited by NABL to ISO/IEC 17025 for the parameters on your report. We choose the lab, arrange the sample, follow up until the report is issued and explain the results to you.

What our clients say

“Instacertify helped us get BIS CRS certification for our entire product range within just 6 weeks. Their team handled everything from documentation to lab coordination. Highly professional service.”

Akash GuptaBIS CRS · Electronics brand

“They handled complete certification for us, from ISO 9001 to BIS for PVC cables and plugs. Thorough, professional and always available — they knew what needed to be done and when.”

Shivank VishnoiISO 9001 & BIS · Cables

“Getting TEC approvals for our access-control products seemed confusing and complex, but Instacertify made it simple.”

Jiten ShahTEC approval · Access control

Not sure which certification you need?

Send us the product name and the countries you sell in. A specialist replies with the standards that apply, the documents to prepare, the lab cost and the timeline. The assessment is free.

The list of approvals comes to you in writing
Get Started with the Right Expert
Testing, certification and registrations handled by one team

+91 99991 18039 WhatsApp us

Get a free assessment