Regulatory Submissions Services That Get Products Approved — First Time
Sub-headline: Expert regulatory submission consulting and global product registration services for pharmaceutical and medical device companies. RABT Global manages your dossier from preparation to approval.
Request a Submission Readiness Assessment Get expert regulatory filing services and health authority submission support for your product — worldwide.
Regulatory submissions services are the critical gateway between your product development and its approval for sale. A flawed or incomplete regulatory submission can delay your product launch by months — or years — and cost your business significantly in lost revenue and remediation costs. At RABT Global, our regulatory submission consulting services are built to get your submission right, first time.
Our specialist team provides regulatory dossier preparation, CTD dossier submission services, and full health authority submission support across all major global markets. Whether you are pursuing pharmaceutical product registration with the FDA, EMA, or MHRA, or seeking global product registration support across multiple markets simultaneously, RABT Global has the expertise and the process to deliver.
From initial regulatory filing services through to lifecycle submission management post-approval, our end-to-end regulatory submissions services cover everything your product needs to achieve and maintain global market access. We manage the complexity so you can focus on your business.
Our Regulatory Submission Approach
Expert guidance through the regulatory submission process
Regulatory Strategy Assessment
We assess your product, target markets, and submission history to map the optimal submission strategy and timeline.
Dossier Gap Analysis
Our team reviews existing documentation against regulatory requirements and identifies gaps requiring completion.
Dossier Preparation
Our regulatory submission consulting team compiles, writes, and quality-checks your complete CTD dossier.
eCTD Publishing & Validation
We publish your submission in eCTD format (where required) and conduct pre-submission validation checks.
Health Authority Submission
We submit your dossier to the relevant health authority and track receipt, filing acceptance, and review progress.
Query Management & Approval Support
We manage all health authority queries, deficiency letters, and supplemental requests through to approval.
MARKETS COVERED — REGULATORY SUBMISSIONS
| Region | Agency | Submission Type |
|---|---|---|
| USA | FDA | NDA, ANDA, BLA, 510(k), PMA, IND, DMF |
| European Union | EMA / National CAs | MAA, CTD, IMPD, EU MDR Technical File |
| United Kingdom | MHRA | UK MAA, UKCA, MHRA rolling review |
| India | CDSCO | Form 44 (drugs), MD-14 (devices), CTA |
| Saudi Arabia | SFDA | Pharmaceutical & device registration |
| UAE | MOHAP / Dubai Health | Drug & device product registration |
| Canada | Health Canada | NDS, ANDS, Class II-IV device licences |
| Australia | TGA | ARTG registration, AUST R/L listings |
Our Regulatory Submissions & Product Registration Services
Expert regulatory submission services for pharmaceutical and medical device companies
CTD Dossier Preparation
full Common Technical Document (CTD) dossier compilation for global submissions
eCTD Submission Management
eCTD lifecycle management, publishing, and electronic submission to FDA, EMA, and beyond
New Drug Applications (NDA/MAA)
preparation and submission of NDA, MAA, BLA, and equivalent applications
Generic Drug Registrations (ANDA/ASMF)
ANDA filings, ASMF preparation, and generic product registration services
Medical Device Registration
FDA 510(k), PMA, CE technical file, EU MDR, and global device registration support
Product Registration in Emerging Markets
GCC, CDSCO, TGA, Health Canada, ANVISA product registration services
Variations & Post-Approval Changes
Type I/II variations, Prior Approval Supplements, and lifecycle submission management
Health Authority Query Management
timely, expert responses to regulatory deficiency letters and health authority questions
What is a Regulatory Submission?
A regulatory submission is a formal application submitted to a health authority (such as the FDA, EMA, or MHRA) requesting approval, clearance, or registration of a pharmaceutical drug, medical device, biologic, or other regulated product. Regulatory submissions typically contain technical, clinical, and quality documentation compiled in a structured format (such as CTD or eCTD). Professional regulatory submissions services ensure that these documents meet all agency requirements, minimising deficiencies and delays.
Regulatory Submissions — Frequently Asked Questions
A: The Common Technical Document (CTD) is an internationally agreed format for organising pharmaceutical regulatory submissions across ICH member regions (FDA, EMA, Japan PMDA, and others). It consists of five modules covering administrative information, quality, non-clinical, and clinical data. RABT Global provides expert CTD dossier submission services for all major markets.
A: Timelines vary by market and product type. FDA NDA standard review: 12 months. EMA centralised procedure: 210 days (active). MHRA: 210 days. CDSCO: 9–12 months. GCC markets: 6–18 months depending on country. RABT Global’s regulatory filing services include realistic timeline planning from the outset.
A: Yes. RABT Global specialises in global product registration support — coordinating parallel submissions across multiple markets to accelerate your global launch timeline. We provide a centralised submission strategy with market-specific adaptation.
A: Lifecycle submission management involves managing all post-approval regulatory activities for your product — including variations, renewals, label updates, and safety-related changes. RABT Global provides proactive lifecycle submission management to keep your product registrations current and compliant in every market.
Ready to Submit? Let RABT Global Manage Your Regulatory Filing
Request Your Submission Readiness Assessment