Gap report
Prepared, reviewed and organised for your gmp certification support engagement.
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GMP Certification Support
Good Manufacturing Practice readiness for pharma facilities.
Expert-ledregulatory support.
Starting price₹32999
Service modeOnline & Offline
Typical duration10–20 weeks
CoveragePan India
The service
Professional support,
Professional support,
clearly explained.
AuthorityApplicable Drugs Control Authority or certification programme
EligibilityOperational pharmaceutical facility with implemented GMP controls
ValidityDepends on applicable GMP certificate and inspection cycle
The License Sathi Promise
We believe in applicability first. Our compliance specialists run pre-checks on your documents and premises layout drawings before filing with the authority. This reduces rejection rates by over 80%.
Need custom assistance?
- hello@licensesathi.in
- Average response: 1 business day
- All states and Union Territories covered
GMP compliance support focused on facility practices, controlled documentation, training, audit preparation and corrective actions.
What's included
- GMP gap assessment
- SOP and record review
- Personnel training
- Mock inspection
Typical documents required
- Site master file
- Quality manual and SOP system
- Batch manufacturing and packaging records
- Validation, qualification and calibration records
- Training, deviation, CAPA and self-inspection records
Requirements can vary by state, device class, business structure and authority queries. We confirm the final checklist after an applicability review.
What you receiveA clearer path from
A clearer path from
requirements to readiness.
The engagement is structured around usable outputs—not vague advice—so your team can see what has been reviewed, prepared and submitted.
SOP framework
Prepared, reviewed and organised for your gmp certification support engagement.
Training records
Prepared, reviewed and organised for your gmp certification support engagement.
CAPA tracker
Prepared, reviewed and organised for your gmp certification support engagement.
Your service journeyEvery stage has a
Every stage has a
defined next step.
You receive a practical view of progress from the first applicability check through filing and authority follow-up.
Applicability review
We confirm how GMP Certification Support applies to your organisation, location and intended activities.
Gap and document review
Your available records are checked against the authority checklist and practical readiness requirements.
Preparation and filing
Forms, declarations and supporting evidence are organised into a submission-ready application.
Tracking and resolution
We track progress, coordinate clarifications and help close authority observations through the decision stage.
“A strong application is not just a collection of documents. It is a consistent evidence trail showing that the people, premises, processes and controls meet the applicable requirement.”
License Sathi Compliance DeskPractical, document-led regulatory support
Common questionsBefore you
Before you
get started.
Clear answers to the questions clients usually ask before beginning GMP Certification Support.
Who should apply for GMP Certification Support?+
Operational pharmaceutical facility with implemented GMP controls. We confirm exact applicability during the initial review.
How long does the process usually take?+
A typical engagement is planned for 10–20 weeks. Actual authority timelines can vary based on location, application completeness, inspection scheduling and queries.
Can License Sathi guarantee approval?+
No consultant can ethically guarantee a government or certification decision. We improve readiness, accuracy and response quality while the competent authority retains final discretion.
Will I receive a final document checklist?+
Yes. After the applicability review, we provide a requirement-specific checklist and identify missing, expiring or inconsistent records before filing.