Due Diligence / Gap Assessments

Overview

Due diligence and gap assessments help organizations understand the current state of a facility, system, product, supplier, or business before making critical decisions such as acquisition, partnership, expansion, remediation, technology transfer, or regulatory submission.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent due diligence and compliance gap assessments for pharmaceutical, biopharmaceutical, API, medical-device, clinical, laboratory, and other regulated organizations.

Our multidisciplinary team evaluates quality systems, manufacturing controls, facilities, engineering, validation, regulatory status, data integrity, computerized systems, pharmacovigilance, EHS, and other relevant areas depending on the scope.

MGS focuses on identifying key risks, highlighting priority gaps, and providing practical recommendations that support informed decision-making and targeted improvement.

Our Due Diligence & Gap Assessment Services

Regulatory Due Diligence

Assessment of regulatory status, licenses, approvals, inspection history, commitments, submissions, and potential compliance risks.

GMP & Quality Gap Assessments

Evaluation of manufacturing, quality systems, laboratories, documentation, validation, and compliance controls against applicable regulatory expectations.

Facility & Engineering Due Diligence

Review of facility design, utilities, HVAC, equipment, maintenance, capacity, qualification status, and engineering risks.

Validation Gap Assessments

Assessment of facility, utility, equipment, process, cleaning, and computerized-system validation status to identify lifecycle gaps.

Data Integrity Assessments

Evaluation of paper and electronic data practices, audit trails, access controls, review systems, data governance, and record reliability.

CSV & Digital Systems Assessments

Review of computerized-system inventories, validation status, electronic records, system controls, cybersecurity interfaces, and digital compliance risks.

Supplier & Partner Due Diligence

Evaluation of potential suppliers, contract manufacturers, laboratories, CROs, service providers, and other business partners before qualification or engagement.

Acquisition & Investment Due Diligence

Independent assessment of quality, regulatory, technical, operational, and compliance risks to support acquisitions, partnerships, investments, or site selection.

Pre-Inspection Gap Assessments

Focused assessments to identify potential regulatory findings before an upcoming inspection or customer audit.

Remediation Gap Assessments

Evaluation of existing systems following regulatory observations, recurring deviations, quality failures, or major compliance concerns.

Key Assessment Areas

Depending on the project scope, MGS may assess:

• Regulatory licenses and approvals
• Inspection history
• Regulatory commitments
• Quality Management System
• Manufacturing operations
• Laboratory controls
• Documentation systems
• Data integrity
• Computerized systems
• Facilities and utilities
• HVAC and cleanrooms
• Equipment lifecycle
• Qualification and validation
• Process and cleaning validation
• Supplier oversight
• Contracted activities
• Pharmacovigilance systems
• Training and competency
• Deviations and investigations
• CAPA
• Change control
• Complaint and recall systems
• EHS risks
• Business continuity
• Capacity and operational readiness
• Expansion or remediation requirements

When Due Diligence Is Valuable

MGS assessments can support organizations during:

• Acquisition or merger evaluations
• New supplier or partner selection
• Site selection
• Facility expansion
• Greenfield or brownfield projects
• Technology transfer
• Product transfer
• Regulatory submission planning
• Pre-inspection readiness
• Major remediation programs
• Outsourcing decisions
• Strategic investment decisions
• Change in ownership or operational model

Our Assessment Process

• Define Objective

Understand the business decision, facility or system scope, regulatory markets, timelines, and key areas of concern.

• Review Information

Evaluate available documentation, inspection history, licenses, reports, quality records, validation documents, and other relevant information.

• Assess

Perform on-site or remote review through interviews, document assessment, facility walkthroughs, data review, and evidence verification.

• Prioritize Risks

Classify identified gaps according to their potential impact on compliance, product quality, patient safety, business continuity, and investment decisions.

• Report

Provide a clear assessment report summarizing key findings, risks, priority gaps, and recommended actions.

• Support Action Planning

Where required, MGS can support remediation planning, CAPA development, project prioritization, and follow-up assessments.

Assessment Deliverables

Depending on the agreed scope, MGS can provide:

• Due diligence assessment plan
• Gap-analysis checklist
• Executive summary
• Detailed assessment report
• Key risk register
• Gap prioritization
• Regulatory and compliance risk summary
• Facility and validation status overview
• Remediation roadmap
• CAPA recommendations
• Follow-up assessment support

Why Choose MGS for Due Diligence & Gap Assessments

Multidisciplinary Expertise

MGS can combine quality, regulatory, engineering, validation, computerized-system, pharmacovigilance, laboratory, and EHS perspectives within one assessment.

Independent Evaluation

Objective third-party assessment helps organizations make more informed decisions before committing significant resources.

Risk-Based Prioritization

Identified gaps are evaluated based on potential impact so clients can focus on the most critical issues first.

Practical Recommendations

Our assessments are designed to translate findings into clear, actionable improvement priorities.

Business & Compliance Perspective

MGS considers both regulatory risk and operational feasibility, helping clients understand the practical significance of identified gaps.

Flexible Scope

Assessments can be targeted to a single system, facility, supplier, product, or broader business transaction.

Who We Support

MGS can support due diligence and gap assessments for:

• Pharmaceutical companies
• API manufacturers
• Finished dosage form facilities
• Biopharmaceutical organizations
• Medical-device companies
• Investors and business partners
• Contract manufacturers
• CROs and laboratories
• Suppliers and vendors
• Warehouses and distribution partners
• Greenfield and brownfield projects
• Other regulated life-sciences organizations