Gap analysis
Our senior experts assess the facility against the target standard and identify every gap.
Gap Analysis
Gap Analysis for Pharma and Medical Device Manufacturing Facilities
On-site, PAN India: a clear picture of where your facility stands today, and what it will take to get where you want to be.
Before an existing facility takes on a new product, a regulated export market or a higher regulatory standard, management needs one answer first: can this plant do it, and if not, what has to change? Upgrading from a State FDA / CDSCO licence to EU GMP, EU MDR or US FDA standards affects the layout, utilities, quality systems, processes, validation and people.
Suchigo Consulting carries out a senior-led gap analysis of your facility. We visit the site, wherever it is in India, assess the plant against the standard you are targeting, and give your management a complete report of the gaps and what is needed to close them. Our support is open to manufacturers and investors from India and overseas.
What We Assess
A practical review across the facility
Each assessment considers how the current plant, systems and team align with the standard you are targeting, and what that means for your next steps.
| Area | What we review | What it tells you |
|---|---|---|
| Facility and layout | Building, master layout, personnel and material flow, segregation and cleanroom zoning | Whether the layout can meet the target standard or needs to be redesigned |
| Utilities and engineering | HVAC, water systems, compressed air, power and other critical utilities | Whether utilities can support the required classification and capacity |
| Quality management system | QMS documentation, SOPs, change control, CAPA, deviations and records | Whether the quality system meets the target regulatory standard |
| Processes and validation | Process controls, equipment qualification, process and cleaning validation | What needs to be qualified, validated or revalidated |
| Manpower and organisation | Key roles, skills, depth of the QA, production and engineering teams | Whether the team can run the facility at the higher standard |
| Regulatory approvals | Current licences and the approvals needed for the target market | The regulatory path and the steps to get there |
From Gap Analysis to Upgrade
Turn findings into a considered action plan
Support can continue from the initial assessment through planning and upgrade execution, based on the scope you choose.
New master layout
Where needed, we advise on a revised layout for flow, cleanrooms and utilities.
Action plan
We set out the upgrades needed to the QMS, processes and validation, with priorities.
Expansion execution
We advise and coordinate consultants and contractors through execution, qualification and regulatory approval.
How It Works
A clear process, with your team in control
From agreeing the objective to deciding what happens next, the engagement is shaped around your facility and your priorities.
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01
Objectives
We agree the product, market and standard you are targeting.
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02
Site visit
We travel to the facility, PAN India, and assess it first-hand.
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03
Report to management
Your management receives a complete gap analysis report covering where the facility stands, each gap, and what is needed to close it, with indicative priorities.
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04
Your choice
You can hand Suchigo the complete upgrade or only the areas your team cannot handle. We work alongside your team as catalyst and advisor, across facility planning, utilities, QMS, validation, manpower and regulatory approvals.
Why Suchigo Consulting
Senior experience. Independent advice.
Senior-led assessments
Led by Mr. Sunil Gokhale, with over 43 years of CEO-level experience, our senior experts assess your facility and report directly to management.
International standards experience
Our team has upgraded facilities to ISO, US FDA, WHO-GMP, MHRA, CE and ANVISA standards and faced inspections by multiple international authorities, with a wide network of industry specialists to draw on.
Confidential and independent
We know which gaps hold up an approval and which can wait. Our advice is independent, all decisions remain with you, and assessments are carried out under strict confidentiality.
Frequently Asked Questions
Gap analysis, explained
What is a gap analysis for a pharma or medical device facility?
It is an assessment of an existing facility against the standard it needs to meet. Suchigo Consulting reviews the layout, utilities, quality systems, processes, validation, manpower and approvals, and reports every gap to management.
When does a manufacturer need a gap analysis?
Before upgrading from a State FDA / CDSCO licence to EU GMP, EU MDR or US FDA standards, before adding a new product or regulated export market, or before expanding an existing plant.
Who carries out the gap analysis?
Suchigo Consulting’s senior experts carry it out on-site. The report goes directly to your management.
What happens after the gap analysis report?
You decide. Suchigo Consulting can advise on the complete upgrade or only the areas your team cannot handle, working alongside your team as catalyst and advisor.
Do you carry out gap analysis anywhere in India?
Yes. Suchigo Consulting carries out gap analysis for pharma and medical device facilities PAN India, for manufacturers and investors from India and overseas.
PAN India Pharma and Medical Device Projects
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