01Pharmaceutical (Rx)
Prescription medicines from development to approval.
Ensuring compliance. Delivering trust.
Pharmaceutical Regulatory Consulting for Global Market Access
Expert guidance for pharmaceutical and biotechnology companies navigating FDA, TGA and EMA regulatory requirements.
TGA Regulatory Support· EMA Regulatory Guidance·Regulatory Strategy·eCTD Submissions·Australian Market·Audit Readiness·
Welcome to Trans-Pacific Compliance
Simplifying Pharmaceutical Regulatory Challenges
At Trans-Pacific Compliance, we specialize in navigating the intricate regulatory landscape of the pharmaceutical industry with precision and expertise. Our mission is to bridge the gap between innovative pharmaceutical companies and the complex regulatory requirements that govern drug approval and market entry.
- One partner for the U.S. and Australia
- Strategy through to submission
- Audit and inspection readiness
- Direct liaison with regulators
Who We Are
Partner in Pharmaceutical Regulatory Compliance.
Trans-Pacific Compliance is a U.S./Australian based regulatory consulting firm dedicated to providing comprehensive solutions for pharmaceutical companies seeking to ensure compliance with regulators, including FDA and TGA and the EMA.
Free Consultation
What We Do
End-to-end regulatory support
Four disciplines that carry a product from first plan to market — and keep it there.
Our Promise
At Trans-Pacific Compliance, we are dedicated to helping you navigate the regulatory landscape with confidence. Our goal is to streamline the regulatory process, ensuring that your products reach the market swiftly and in compliance with all regulatory requirements.
Service finder
Find the right starting point
Three quick questions — we'll suggest where TPC can help first.
We're Delivering the Best Quality and Regulatory Affairs Agent Across the Globe
Why Choose Us
A partner built for regulatory success
With a deep understanding of the regulatory environment and a track record of successful submissions and approvals, Trans-Pacific Compliance is your trusted partner in achieving regulatory success. We pride ourselves on our commitment to excellence, integrity, and personalized service.
01
Global presence
Teams on both sides of the Pacific.
02
Proven track record
Successful submissions and approvals across multiple markets.
03
Strategy to submission
One team from first plan to final filing.
04
Inspection readiness
Practical preparation for FDA and TGA audits.
05
Direct regulator liaison
We manage the conversation with agencies.
06
Personalized service
Senior attention, scaled to your product.
07
Clear communication
Plain answers, regular updates, no jargon walls.
08
Flexible engagement
Project-based, ongoing or on-call support.
Who we serve
Built for regulated products
01
02Generics
ANDA and generic registrations built on solid comparisons.
03Biotech and biologics
Complex products with complex data packages.
04Medical devices
Classification, premarket and post-market support.
05OTC and complementary medicines
Lower-risk products still need the right route.
06Overseas companies
Entering the U.S. or Australia from abroad.
Our commitments
How we work with you
Tailored to your product
No template strategies. We start from your product, data and goals, and build the pathway around them.
Personal guidance from start to finish
A consistent point of contact who knows your file and stays with you through every milestone.
A trusted partner on both sides of the Pacific
Coordinated U.S. and Australian work, so your submissions move forward in step rather than in silos.
Testimonials
What our clients
are saying
5.0/ 5
Based on Google Reviews
News & Articles
Insights from the regulatory front line
FAQ
Common questions
This content is general information only and is not legal or regulatory advice.
Generally, yes. Therapeutic goods supplied in Australia must be included on the ARTG by an Australian sponsor — an Australian resident or business that takes legal responsibility for the product. Overseas companies typically appoint a sponsor or work with a provider who can support that role.
Get in touch
Talk to a regulatory
specialist today
Whether you're planning your first FDA submission, navigating TGA requirements, or need ongoing compliance support — our team is ready to help. Tell us about your product and we'll outline the right path forward.
Email us
enquiries@tpccompliances.comCall us
+1 706-773-4965Offices
Sydney, NSW, Australia
United States
Book a free consultation
No commitment. We'll respond within one business day.