Submission Preparation & Management

Submission Preparation and Management

End-to-end submission management for FDA, TGA and global regulatory applications — prepared to the highest quality standard.

Comprehensive Regulatory Submissions Prepared to the Highest Standard

A well-prepared submission is the single most important factor in achieving timely approval. Trans-Pacific Compliance manages the full lifecycle of your regulatory submissions — from initial planning and gap analysis through preparation, review and lodgement with the FDA, TGA or other agencies.

We coordinate across your CMC, clinical and nonclinical teams to produce submissions that are complete, consistent and formatted to current agency standards.

Dossier and regulatory review documents on a desk

Comprehensive Submission Packages

We prepare thorough, accurate regulatory submissions across all major application types — INDs, BLAs, NDAs, ANDAs, 505(b)(2)s, DMFs, ARTG applications and device premarket submissions. Every document is reviewed for completeness, consistency and compliance with current agency requirements.

Our team handles both eCTD and non-eCTD formats, managing the full document chain from authoring through quality review to final submission.

IND, NDA, ANDA, 505(b)(2), BLA, DMF preparation
ARTG registration and TGA dossier management
510(k), De Novo and PMA preparation
eCTD publishing and SPL labeling
Submission gap analysis and readiness review

Professional reviewing and signing business planning documents

Quality Assurance for Submissions

Every submission we produce goes through a structured quality review before lodgement. We check for scientific consistency across modules, formatting compliance with agency guidance, and completeness of the document package.

Our QA process is designed to catch the issues that cause information requests and refuse-to-file decisions — protecting your timeline.

Cross-module consistency review
Agency formatting and eCTD validation
Pre-submission quality check against agency guidance
Labeling review and compliance verification
Timeline management and submission tracking

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Regulatory Agency Coordination

We manage the review interaction from submission through to approval — handling information requests, responding to agency questions and facilitating any required meetings. Our team acts as the interface between your organisation and the FDA or TGA.

We keep the review moving and your internal teams focused on their core work.

Agency information request (IR/AIR/CR) responses
Review meeting preparation and management
Complete Response Letter (CRL) response strategy
TGA evaluation question responses
Post-submission tracking and status management

Who this is for

Pharmaceutical, biotech, generic and device companies preparing first submissions, managing ongoing submissions, or responding to agency requests across any market.

Get in touch

Whether you need a full submission team or support for a specific module, contact us to discuss your submission timeline and requirements.

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