Compliance & Risk Management

Compliance and Risk Management

Proactive compliance management, inspection readiness and quality systems support for pharmaceutical and device companies.

Stay Ahead of Regulatory Change with Proactive Compliance Management

Compliance is an ongoing operational discipline, not a pre-inspection checklist. Trans-Pacific Compliance helps pharmaceutical and device companies monitor the regulatory landscape, prepare for FDA and TGA inspections, and manage the post-approval changes that arise throughout a product's lifecycle.

From GMP audit readiness and CAPA support through to quality systems design and variation management, we provide practical compliance support tailored to your organisation.

Dossier and regulatory review documents on a desk

Ongoing Compliance Monitoring

We provide ongoing regulatory monitoring to keep your products, labeling and manufacturing processes current with FDA, TGA and ICH requirements. Our monitoring covers regulatory guidance updates, agency inspection trends and enforcement activity.

You get early warning of changes that could affect your compliance posture — before they become a problem.

FDA, TGA and ICH guidance tracking
Regulatory change impact assessment
Labeling and promotional materials compliance review
Post-market surveillance and reporting obligations
Annual product review support

Professional reviewing and signing business planning documents

Audit and Inspection Preparation

A regulatory inspection tests your documentation, your people and your quality culture. We prepare companies for FDA and TGA inspections through structured readiness programmes — identifying gaps, fixing them, and ensuring your team responds confidently when inspectors arrive.

Our readiness work includes documentation audits, mock inspections, back-room team preparation and SOP review.

Pre-inspection documentation audit
Mock FDA and TGA inspections
Back-room team training and preparation
SOP review and gap remediation
GMP audit response and CAPA development

Professionals planning strategy together at laptops

Risk Assessment and Mitigation

We provide structured risk assessments across your quality systems, manufacturing processes and post-approval obligations — identifying, assessing and controlling risks before they become compliance failures.

Our risk management support covers change control impact assessment, CAPA effectiveness monitoring and post-approval variation risk evaluation.

ICH Q9 quality risk management frameworks
Change control impact assessment
CAPA root cause analysis and effectiveness checks
Supplier qualification and monitoring
Post-approval lifecycle and variation management

Who this is for

Pharmaceutical manufacturers, CMOs and sponsors seeking to build, maintain or improve their regulatory compliance posture — including companies preparing for FDA or TGA inspections or responding to audit findings.

Get in touch

Whether you are preparing for an inspection, responding to audit findings or rebuilding a quality system, contact us to discuss your situation.

Book a free consultation +1 706-773-4965

Work with us

Ready to move your product forward?

A free 30-minute consultation with one of our senior regulators costs nothing and can save months of misdirected effort.

Free Consultation