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Regulatory and compliance

Compliance audits

We check your documents, systems and sites against the rules, before a regulator or a client does. Then we help you fix what we find.

What it is

In one sentence

An audit is a planned check of your work against a set of rules. We find the gaps before an inspector does, and tell you how to close them.

Who it is for

Quality and regulatory heads at pharma, medtech, nutraceutical and FMCG companies with an inspection or client audit coming up. Also teams that want to know where they stand.

Problems it solves

Why audits go wrong

  • Surprises on inspection day

    Gaps are found by the inspector, not by you. A mock audit finds them first, while there is still time to fix them.

  • Records that do not match

    Procedures say one thing and records show another. We check that what you wrote down matches what you do.

  • Findings that come back

    A fix that treats the symptom, not the cause, fails at the next audit. We help you find the root cause and write a lasting fix.

What you get

Deliverables

  • An audit plan agreed with you before we start
  • Mock inspections that follow how a regulator works
  • Audits of your sites, systems and suppliers
  • A written report: each finding, how serious it is, and the rule behind it
  • Help writing corrective and preventive actions (CAPA: the steps that fix a problem and stop it coming back)
  • A follow-up check that the fixes work

How it works

From plan to closed findings

  1. Agree the scope

    We agree what to audit, against which rules, and when.

  2. Review the documents

    We read your procedures and records before the visit.

  3. Audit on site or online

    We interview your team and check how work is really done.

  4. Report the findings

    You get a clear report, ranked by how serious each finding is.

  5. Fix and follow up

    We help you plan the fixes, then check that they work.

Regulators and standards

Rules we audit against

CDSCO (India)
India's national regulator for medicines and medical devices.
US FDA
The US Food and Drug Administration, for products sold in the USA.
Good practice rules
GCP (good clinical practice) for trials and GMP (good manufacturing practice) for making products.
Terms explained
Mock inspection: a practice inspection run like the real one. CAPA: corrective and preventive action. Finding: a gap between what the rules ask and what you do.

FAQs

Questions we are often asked

When should we book an audit?

Early. A mock inspection a few months before the real one leaves time to fix what it finds.

Do you audit our suppliers and partner sites?

Yes. We can audit the labs, sites and vendors you rely on, against the same rules.

What happens after the audit?

You get a written report. We help you plan fixes for each finding, and check later that they worked.

Can you help after a real inspection?

Yes. We can help you understand the findings and write your response and your fixes.

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

Get ready before the inspector arrives.

Tell us what is being inspected and when. We will suggest what to audit first.

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