Our Services

Auditing & Inspection Readiness
We deliver authoritative auditing services, including:
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Gap assessments
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Vendor and third-party audits
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Inspection readiness audits
Our audits cover Formulation, APIs, intermediates, key starting materials, excipients, packaging materials, analytical services, and Good Distribution Practices (GDP)—all aligned with global cGxP standards.

Remediation & Culture Building
We design robust compliance remediation programs for enforcement actions issued by international regulatory bodies (e.g., USFDA, MHRA, WHO).
We also help build a compliance-focused culture across both manufacturing and corporate levels through structured change management and training initiatives.

Qualification, Validation & Technology Transfer
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Our end-to-end support includes: Analytical method validation
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Process, cleaning, computer system, facility, and equipment qualification.
Technology transfer for all dosage forms, ensuring regulatory alignment and business continuity.

Assessment of Laboratory Controls (GLP)
We provide in-depth GLP assessments, including:
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Review of analytical procedures Evaluation of laboratory data
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Verification of compliance with Good Laboratory Practice standards

Failure Investigations & CAPA
From root cause analysis to CAPA design, we support the full investigation lifecycle, ensuring each step is scientifically justified and regulatory-ready.
Customized investigation methodologies CAPA initiation, implementation, and tracking

Technical Training & Capability Building
We offer customized training modules covering:
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Global GxP and regulatory expectations
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Data integrity and documentation practices
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Risk management and audit readiness
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Our training empowers teams to maintain a state of continuous compliance.

Establishment of QMS & Digital Transformation
We help design, implement, and optimize:
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Quality Management Systems (QMS)
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Electronic systems including eQMS, LIMS, eBMR, and DMS.
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Digital quality infrastructure aligned with 21 CFR Part 11, Annex 11, and data integrity principles.

Data Integrity Assessments
Thorough review of:
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Laboratory software and electronic records
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Paper-based documentation systems
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Compliance with regulatory guidelines on data integrity across the product lifecycle

Process Simplification Within cGxP Boundaries
We streamline operations while ensuring full regulatory compliance:
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Procedural simplification
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Workflow optimization
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Cost-effective compliance strategies

Support for Regulatory Enforcement Actions
Our team provides full lifecycle support for handling enforcement actions:
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Drafting technical responses for NCs, warning letters, and import alerts.
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Regulatory liaison and representation during meetings
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Strategy for achieving long-term compliance and inspection readiness.


