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Trans-Pacific Compliance

Communication with Regulatory Authorities

Communication with Regulatory Authorities

Strategic liaison with the FDA, TGA and global regulatory authorities — protecting your interests and keeping your regulatory programme on track.

Expert Regulatory Liaison to Protect Your Interests with the FDA and TGA

Effective communication with regulatory authorities is a skill that takes years to develop. Trans-Pacific Compliance acts as your primary liaison with the FDA, TGA and other agencies — managing correspondence, facilitating meetings, and advocating for your regulatory positions with clarity and credibility.

We represent sponsors in all types of agency interactions, from routine queries through to pre-submission meetings, dispute resolution and inspection responses.

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Effective Regulatory Liaison

We serve as your primary point of contact with the FDA, TGA and other regulatory authorities — managing all formal and informal correspondence, tracking agency responses and ensuring every interaction is handled professionally and on time.

Our team understands how agencies communicate and what they expect. We translate your objectives into regulatory language that agencies respond to.

  • FDA and TGA correspondence management
  • U.S. Agent and Australian sponsor services
  • Establishment registration and product listing maintenance
  • Agency query tracking and response management
  • Regulatory submission acknowledgement and tracking
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Negotiation and Regulatory Advocacy

When agencies raise concerns, request additional data or propose labeling restrictions that do not reflect your product's benefit-risk profile, you need an experienced advocate.

We represent your interests in formal dispute resolution processes, negotiate labeling outcomes, and prepare the scientific arguments needed to support your regulatory positions.

  • Complete Response Letter (CRL) strategy and response
  • Formal dispute resolution and TGA objection responses
  • Labeling negotiation and advocacy
  • Pre-submission meeting strategy and preparation
  • Agency briefing document development
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Regulatory Updates and Intelligence

We keep you informed of the regulatory developments that matter to your products and your business — new FDA and TGA guidances, revised standards, shifts in enforcement priorities and international harmonisation updates.

Our regulatory intelligence service provides timely analysis so you can act early rather than react late.

  • FDA and TGA guidance monitoring and analysis
  • ICH and international harmonisation updates
  • Agency inspection trend reporting
  • Product-specific regulatory intelligence
  • Regulatory briefings and update summaries

Who this is for

Any pharmaceutical, biotech or device company with an active regulatory programme — particularly those managing complex agency interactions, entering a new market, or dealing with inspection findings or agency objections.

Get in touch

Managing regulatory authority relationships is best done proactively. Contact us to discuss how we can support your agency interactions.

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