Identify latent risks of product recalls or regulatory action before closing.
Technical and Commercial Due Diligence
Quality Assurance and Regulatory Due Diligence for Pharma and Medical Device Facilities
On-site, PAN India: verifying whether a facility’s quality records match what happens on the shop floor and in the laboratory.
Regulatory non-compliance is one of the biggest risks in a pharmaceutical or medical device acquisition. Unaddressed audit observations, unvalidated test methods or weak contamination controls can lead to rejected batches, warning letters, import alerts or a suspended licence.
Suchigo Consulting provides quality and regulatory due diligence for acquirers, investors and manufacturers from India and overseas. We check whether a facility’s quality controls hold up in practice, measured against CDSCO, pharmacopoeial and international regulatory expectations.
What We Assess
A practical review of facility quality and compliance
Our senior experts compare documented controls with the work taking place in warehouses, cleanrooms and quality control laboratories.
| Area | What we review | What it tells you |
|---|---|---|
| Raw materials, packaging materials and finished goods | Certificates of Analysis, vendor qualification, quarantine and sampling, storage conditions and batch release | Whether materials and products are controlled from receipt to release |
| Technical specifications | Product and material specifications, test methods, batch release criteria and out-of-specification (OOS) investigations | Whether products are defined and tested to the right standard |
| Class 7 and Class 8 cleanrooms | Classification and requalification (ISO 14644), particle counts, air changes, pressure differentials, HEPA integrity and recovery | Whether controlled areas consistently meet their stated classification |
| CFU and sterility testing | Colony Forming Unit (CFU) trends, bioburden testing, sterility test method validation, media fills and investigations of positive results | Whether microbiological results are reliable and support product release |
Value for Investors and Owners
Understand compliance risks before they affect the business
A buyer who inherits a non-compliant cleanroom or unvalidated test methods may face remediation costs, delayed launches or restricted market access. Our assessment helps you:
Understand whether the facility can withstand an inspection by global regulatory authorities.
Use a clear gap analysis as the first step for upgrades to EU MDR, EU GMP or US FDA standards.
How the Assessment Works
From the records to the facility floor
We agree the objectives, review the evidence, verify practice on site and report findings directly to your management.
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01
Scope and document review
We agree the objectives and review specifications, validation reports, environmental monitoring data and audit history.
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02
Site and laboratory visit
We travel to the facility, PAN India, and assess cleanrooms, warehouses and quality control laboratories first-hand.
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03
Gap analysis
Our senior experts compare current practice with applicable regulatory and quality standards and classify each gap by risk.
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04
Report and recommendations
Your management receives a clear report of findings, compliance risks and the corrective actions needed. After the report, Suchigo can advise on implementing corrective actions for the complete upgrade or selected areas, working alongside your team as catalyst and advisor.
Why Suchigo Consulting
Senior experience. Independent perspective.
Led by Mr. Sunil Gokhale, with over 43 years of CEO-level experience, our senior experts have faced regulatory inspections by multiple international authorities and built facilities to ISO, US FDA, WHO-GMP, MHRA, CE and ANVISA standards, with a wide network of industry specialists to draw on.
We know what inspectors look for, and how quality gaps show up on the shop floor long before they appear in an audit report. We work alongside your team as catalyst and advisor. All assessments are carried out under strict confidentiality.
Frequently Asked Questions
Quality and regulatory due diligence, explained
What is quality and regulatory due diligence?
It is an independent assessment of a facility’s quality controls and regulatory compliance. Suchigo Consulting reviews material and product validation, specifications, cleanroom performance and microbiological testing.
Does Suchigo Consulting assess Class 7 and Class 8 cleanrooms?
Yes. Suchigo Consulting assesses the classification, requalification and environmental monitoring of Class 7 and Class 8 cleanrooms, including air changes, pressure differentials and HEPA filtration.
Why is CFU and sterility testing validation important?
CFU and sterility testing confirm that products and controlled areas meet microbiological limits. If methods are not validated, results cannot be relied on for product release or regulatory submissions.
Can this assessment support a regulatory upgrade?
Yes. Manufacturers moving from a State FDA / CDSCO licence to EU MDR, EU GMP or US FDA standards can use it as a gap analysis before planning upgrades to quality systems, processes and validation.
Can quality and regulatory due diligence be combined with other services?
Yes. It can be combined with our technology, QMS, HR, operational and commercial due diligence services for a complete technical and commercial due diligence of the facility.
PAN India Pharma and Medical Device Projects
Connected to India? Talk to us.
Share your requirement, and we’ll help you see where the facility stands on quality and compliance.
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