Audits & Gap Assessments
Regulatory inspection and audit response support
How you respond to inspection observations matters as much as the findings themselves. We help you write responses that show you understand each observation, have found the root cause and have a credible plan to correct it — supported by evidence.
- Typical findings Regulatory inspection observations, customer audit findings
- Typical inputs Inspection report or list of observations, initial investigations
- You receive Response document, CAPA plan and evidence index
Overview
About Audit Response Support
A strong response addresses each observation individually, acknowledges it where appropriate, explains the investigation and root cause, assesses the impact on product already released, and sets out corrective and preventive actions with realistic dates. Weak responses that only fix the specific example often lead to repeat observations.
We work alongside your QA team to structure the response, challenge root causes, draft the text and assemble the supporting evidence.
Use cases
When this service helps
After a regulatory inspection
Respond to observations within the authority’s timeline.
After a customer audit
Address major findings that put a supply relationship at risk.
Follow-up inspections
Show that previous commitments have been met.
Import alerts or restrictions
Support the evidence needed to demonstrate remediation.
Scope
What the service covers
- Review of each observation and the underlying requirement
- Root-cause analysis support and challenge
- Impact assessment for released product
- CAPA plan with owners, dates and effectiveness checks
- Drafting the response letter and organising evidence
- Progress updates and commitment tracking
Who does what
Responses are submitted by, and remain the responsibility of, your company. Globaxa helps prepare them; we do not negotiate with authorities on your behalf unless specifically agreed.
What makes a CAPA plan credible?
Actions that address the root cause rather than the symptom, a review of whether the issue affects other areas, realistic dates, named owners and a defined check that the action worked.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Understand the findingsEach observation is mapped to the requirement and evidence.
- InvestigateRoot cause and impact are established for each.
- Plan actionsCorrective and preventive actions with realistic dates.
- Draft and assembleResponse text and evidence index are prepared for your sign-off.
Deliverables
What you receive
Response document
Observation-by-observation response ready for your signature.
CAPA plan
Actions, owners, due dates and effectiveness checks.
Evidence index
Organised references to supporting documents.
Technical basis
Guidelines we work to
- ICH Q10CAPA and management review within the pharmaceutical quality system.
- US FDA practiceFDA considers responses received within 15 business days of a Form FDA 483 when deciding on further action.
- Authority-specific proceduresEach inspectorate sets its own response format and deadline; the inspection report or closing meeting will state them.
What we need from you
- Inspection report or list of observations
- Any initial investigations and evidence gathered
- Response deadline and authority contact details
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
Response formats and deadlines differ between authorities. We follow the format requested by the inspectorate and the timelines stated in the inspection documents.
FAQs
Audit Response Support: frequently asked questions
Can you start before the inspection report arrives?
Yes. Starting on investigations immediately after the closing meeting gives you more time for a quality response.
Do you guarantee the authority will accept the response?
No. The authority makes its own assessment. A clear, evidenced response gives you the best chance of a positive outcome.
Can you help after a warning letter?
Yes. We can help structure the response and the remediation programme.
Talk to us about Audit Response Support
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST