Objective: Resolve compliance gaps and recover from regulatory observations or warning letters.

We specialize in helping companies respond effectively to:

• FDA Form 483 observations

• EMA or Health Canada deficiency letters

• Third-party audit findings

Our remediation services include:

• Root cause analysis (RCA) aligned with industry best practices

• CAPA planning, execution, and effectiveness checks

• Documentation clean-up and reconstruction

• QMS rebuilding or redesign

• Remediation project management and interim QA leadership

• Communication strategies for regulators (response letters, updates, milestones)

Whether you’re recovering from an inspection or preparing a proactive remediation plan, we help you regain regulatory confidence — quickly and sustainably.

Objective: Identify and address compliance gaps before regulators do.

We perform comprehensive internal GMP audits modeled after regulatory inspections (FDA, EMA, Health Canada) and aligned with PIC/S standards. Our audits evaluate:

• QMS structure and implementation

• SOPs and records

• Facility and equipment controls

• Personnel training and hygiene

• Batch documentation

• Data integrity risks

A detailed gap report outlines deficiencies, risk levels, and prioritized corrective actions.

Objective: Prepare confidently for real inspections.

We simulate regulatory inspections under FDA (PAI, GMP surveillance), EMA (GMP compliance), or Health Canada frameworks. Services include:

• Inspection coaching and mock interviews

• Readiness assessments for documentation, site conditions, and personnel

• Custom inspection playbooks

• Risk mitigation plans for known findings

This is ideal before a market authorization application or facility expansion.

Objective: Build or improve systems that support compliant operations.

We help develop or remediate GMP-compliant SOPs and QMS elements including:

• SOP architecture & formatting

• Document control systems

• Change control procedures

• Deviations, CAPAs, and investigations

• Quality risk management (ICH Q9)

• Training systems

Support includes drafting, revising, and implementing SOPs tailored to your operations — whether for clinical or commercial manufacturing.

Objective: Build a robust, inspection-ready QMS — from the ground up.

We help implement and validate Quality Management Systems tailored to your product lifecycle stage (clinical, commercial, or tech transfer). Services include:

• End-to-end QMS design aligned with ICH Q10, EMA, FDA, and Health Canada GMPs

• Selection and configuration of eQMS platforms (MasterControl, Veeva, etc.)

• SOP creation and hierarchy mapping

• Process validation documentation and strategy

• System validation (CSV/CSA) aligned with GAMP 5 and data integrity principles

• Training program setup and effectiveness checks

Whether you're a start-up launching GMP operations or an established company overhauling outdated systems, we ensure your QMS is practical, scalable, and compliant.

Objective: Ensure trustworthy records and regulatory defensibility.

We assess data governance practices using ALCOA+ principles and help implement:

• Audit trails and system validations

• Secure access control

• Paper and electronic record compliance

• Logbook reviews and corrections

• Procedures for raw data handling and storage

This service is critical in preparation for FDA or EMA inspections focused on data integrity.

Objective: De-risk your supply chain by ensuring vendor compliance.

We support full lifecycle vendor management including:

• Third-party GMP audits

• Technical agreements and quality clauses

• Vendor qualification packages

• Ongoing oversight and scorecards

• Remote audit strategies (post-COVID hybrid models)

We help you manage CMOs, CDMOs, API suppliers, labs, and packaging vendors to ensure they meet regulatory expectations.