We deliver authoritative auditing services, including:

• Gap assessments

• Vendor and third-party audits

• 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.

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.

• Our end-to-end support includes: Analytical method validation

• Process, cleaning, computer system, facility, and equipment qualification.

 

Technology transfer for all dosage forms, ensuring regulatory alignment and business continuity.

We provide in-depth GLP assessments, including:

• Review of analytical procedures Evaluation of laboratory data

• Verification of compliance with Good Laboratory Practice standards

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

We offer customized training modules covering:

• Global GxP and regulatory expectations

• Data integrity and documentation practices

• Risk management and audit readiness

• Our training empowers teams to maintain a state of continuous compliance.

We help design, implement, and optimize:

• Quality Management Systems (QMS)

• Electronic systems including eQMS, LIMS, eBMR, and DMS.

• Digital quality infrastructure aligned with 21 CFR Part 11, Annex 11, and data integrity principles.

Thorough review of:

• Laboratory software and electronic records

• Paper-based documentation systems

• Compliance with regulatory guidelines on data integrity across the product lifecycle

We streamline operations while ensuring full regulatory compliance:

• Procedural simplification

• Workflow optimization

• Cost-effective compliance strategies

Our team provides full lifecycle support for handling enforcement actions:

• Drafting technical responses for NCs, warning letters, and import alerts.

• Regulatory liaison and representation during meetings

• Strategy for achieving long-term compliance and inspection readiness.