The regulatory submission process is an important, if complex, part of bringing a new product to market.
Whether you’re developing a drug, medical device, diagnostic, or combination product, submitting to a regulatory agency is how you move from development to delivery, and most importantly, get your product into the hands of the patients it's designed for.
The specifics can vary depending on the type of product and market, nut the core principles remain the same: communicate clearly, meet regulatory expectations, and keep every detail organized and traceable.
This guide offers a clear, high-level view of the regulatory submission process. It’s designed to help life sciences teams understand what’s involved, how the steps may vary by product type, and what tools and technologies are available to support the work.
We'll cover:
- What the regulatory submission process looks like, start to finish
- How different technologies make the process more efficient and manageable
- How submission requirements differ across drugs, devices, and combination products
Let’s take a closer look at what a submission really involves.
What Is a Regulatory Submission?
At its core, a regulatory submission is a formal request to a government agency for approval to begin or continue a specific activity related to a medical product, usually clinical trials or commercial distribution.
It’s the bridge between your development work and a regulatory decision.
Submissions include detailed documentation to demonstrate that your product is safe, effective, high-quality, and meets the relevant regulatory requirements for the market you’re targeting.
Common Types of Regulatory Submissions
Depending on your product type and where you’re submitting, the terminology and requirements will vary.
Here’s a quick snapshot of the most common submission types:
Drugs (U.S.)
- IND (Investigational New Drug): Required before starting clinical trials
- NDA (New Drug Application): Submitted for market approval
- ANDA (Abbreviated New Drug Application): For generics
Biologics
- IND (same as above)
- BLA (Biologics License Application): For market approval of biologic therapies
Medical Devices (U.S.)
- 510(k): Shows substantial equivalence to an existing device
- PMA (Premarket Approval): Required for high-risk devices
- De Novo: For novel, moderate-risk devices with no predicate
Diagnostics and IVDs
- Often follow device pathways (510(k), PMA)
- EU submissions follow IVDR-specific requirements
Combination Products
- Submitted based on primary mode of action (drug, biologic, or device)
- Often require coordination across multiple regulatory divisions
European Union
- MAA (Marketing Authorisation Application): Required for most drugs and biologics
- Technical Files and Design Dossiers: Used for medical devices under MDR or IVDR
Regardless of submission type, the goal is the same: demonstrate that your product meets the regulatory standards for safety, efficacy, and quality.
Key Phases of the Regulatory Submission Process
While the exact steps will vary based on your product type and regulatory pathway, most submissions follow a common set of phases.
Understanding these stages helps you plan ahead, assign responsibilities, and avoid surprises.
1. Pre-Submission Planning
This is where strategy takes shape. Before you ever submit a document, your team is developing a regulatory plan, identifying target markets, mapping submission timelines, and possibly engaging with agencies through pre-submission meetings (e.g., FDA Pre-IND, EMA Scientific Advice).
This stage is also where you define the structure and scope of your submission content. A well-organized plan makes the entire process smoother later on.
The most useful technologies during pre-submission planning are going to be a strong Regulatory Information Management (RIM) system and regulatory intelligence tools.
A great RIM system helps teams map out what needs to be submitted, when, and by whom. It brings structure to the process early on, making it easier to coordinate across regulatory, clinical, CMC, and quality functions.
Regulatory intelligence tools help your team understand current regulatory requirements by region, assess potential risks, and choose the right submission pathway. This is especially valuable for first-time submissions, new markets, or products in evolving categories like diagnostics or gene therapies.
2. Document Compilation
Once your content plan is in place, it’s time to gather and prepare all the necessary documents. This often includes:
- Clinical trial data and study reports
- Nonclinical safety data
- Manufacturing and CMC documentation
- Product labeling and packaging info
- Administrative forms and certifications
Each document typically goes through multiple rounds of authoring, review, and approval. Version control and traceability are critical, especially when working across internal departments or external partners.
The most useful technology during document compilation is a centralized document management system (DMS), ideally one that is purpose-built for regulatory work.
A great life sciences DMS allows teams to store, organize, and collaborate on documents across functional areas like clinical, nonclinical, CMC, and labeling. More importantly, it helps prevent compliance issues across version control, user permissions, and audit trails.
3. Submission Assembly and Publishing
Once your documents are final, they need to be formatted and organized according to regulatory guidelines, most often in eCTD (electronic Common Technical Document) format for drugs and biologics, or as structured technical files for devices.
This phase includes:
- Linking and formatting documents
- Performing validation checks
- Using publishing tools to build the final submission package
The essential technology during submission assembly and publishing is an eCTD publishing tool, especially for drug and biologic submissions, which require strict formatting, metadata, and validation to be accepted by agencies like the FDA or EMA.
A great eCTD publishing tool helps you build the final submission package, check for technical errors, and ensure everything is formatted correctly before it's sent. Without proper publishing software, even a well-prepared submission can be delayed or rejected due to technical issues.
While not necessarily essential to this process, a great RIM platform makes a big difference during submission assembly. It ensures the documents you’re pulling together are already approved, versioned correctly, and organized in a way that mirrors the final submission structure, so when it’s time to publish, you’re assembling, not scrambling.
4. Submission and Agency Interaction
Now it’s time to submit. Depending on your region, you may upload files to a regulatory portal (like the FDA’s ESG or EMA’s IRIS system) or send them directly to a notified body.
After submission, expect follow-up:
- Agencies may request additional information (e.g., Information Requests, Deficiency Letters)
- You may need to submit responses within tight timelines
- Some products will go through advisory committee reviews or require inspection coordination
Once a submission is sent, the focus shifts to tracking interactions with regulatory agencies and managing requests, correspondence, and follow-up tasks.
The most useful technology during submission and agency interaction is a strong RIM system.
A RIM system with correspondence and commitment tracking gives your team a structured place to log agency communications, assign follow-up tasks, track deadlines, and ensure nothing slips through the cracks. Instead of reacting to requests as they come in, you can respond strategically and with full visibility into what was submitted, when, and by whom.
5. Post-Submission and Lifecycle Management
Approval isn’t the end of the story. Ongoing responsibilities may include:
- Submitting updates and variations
- Tracking post-market commitments
- Managing labeling changes and periodic reports
- Renewing licenses or certificates
After the submission goes out the door, the work doesn’t stop. Teams need to manage post-submission commitments, labeling updates, health authority questions, variations, and renewals, sometimes months or even years after the original submission.
While you can technically track these manually, the more products and markets you support, the harder it becomes to stay on top of everything without missing a deadline or repeating effort.
The most helpful technology during post-submission and lifecycle management is, once again, a strong RIM system.
A RIM system with built-in lifecycle management keeps track of every commitment made to health authorities, every label that needs updating, and every country-specific variation that needs follow-through. Instead of piecing together emails or spreadsheets, your team can see exactly what’s due, when, and why, helping you stay compliant and responsive long after the initial approval.
Common Pitfalls (and How to Avoid Them)
Even the most experienced regulatory teams run into challenges during the submission process. Some of these issues are easy to spot while others only surface when timelines slip or documents go missing.
The good news is that most of these issues are preventable with the right planning, structure, and tools. Here are a few of the most common pitfalls and how to stay ahead of them.
1. Fragmented Document Storage
When submission documents are scattered across email threads, personal folders, SharePoint sites, and local drives, things get lost. And when the clock is ticking, no one wants to hunt for “final_FINAL_v3_clean.docx.”
What helps: Centralizing your documents in a single, controlled system like a DMS or DMS-integrated RIM, ideally one designed for regulatory with access controls, version history, and automated workflows.
2. Lack of Version Control
If multiple people are editing the same document in parallel (or worse, from outdated copies), it’s only a matter of time before something slips through.
What helps: Use tools that track document ownership, changes, and approvals. RIM platforms often include this natively, giving everyone confidence they’re working on the right version.
3. Rushed Reviews and Missed Deadlines
When timelines aren’t clear or approvals get stuck in someone’s inbox, reviews pile up at the last minute. That’s when errors happen, and quality suffers.
What helps: Clear task assignments, automated reminders, and dashboards that show what’s done, what’s pending, and what’s at risk. This is where structured workflows really shine.
4. Submission Formatting Issues
Even strong submissions can be delayed by technical issues: broken links, formatting errors, or missing metadata during eCTD publishing.
What helps: Use publishing tools that validate your submission before you send it. Many RIM platforms white label publishing as a "built-in" feature, while others (our recommendation here at Kivo) integrate with best-in-class publishing software, allowing for more flexibility.
5. Poor Lifecycle Visibility
Once a submission is complete, the work isn’t over. Teams often struggle to track commitments, variations, or labeling changes months (or years) down the line.
What helps: A RIM system with built-in lifecycle tracking keeps ongoing requirements visible and manageable, even as teams change or grow.
Avoiding these pitfalls isn’t about working harder, it’s about building a more sustainable, scalable process.
Submission Process Variations by Product Type
Not all regulatory submissions follow the same playbook. The general principles are consistent, but the content, format, and regulatory pathway can vary significantly depending on what kind of product you’re working on.
Here’s a quick breakdown of how submissions differ across major product categories.
Drugs (Small Molecules)
Typical submissions: IND (for clinical trials), NDA (for market approval), ANDA (for generics)
What’s unique:
- Heavily structured documentation in the Common Technical Document (CTD) or eCTD format
- Emphasis on clinical and CMC data
- Long timelines and phased reviews
- Pre-submission meetings (e.g., Pre-IND, Pre-NDA) are common
Biologics
Typical submissions: IND, BLA (Biologics License Application)
What’s unique:
- Similar to drug submissions but with more complex CMC requirements
- Manufacturing consistency and immunogenicity data are often key focus areas
- Additional post-marketing requirements may apply
Medical Devices
Typical submissions: 510(k), PMA, De Novo, Technical File (EU)
What’s unique:
- Risk-based classification determines the pathway
- Clinical data is sometimes required (for high-risk devices), but often not
- Usability, labeling, and performance testing are critical
- More flexibility in submission format (e.g., not always eCTD)
Combination Products
Typical submissions: Varies depending on the primary mode of action (PMOA)
What’s unique:
- Must meet requirements of multiple product types (e.g., drug + device)
- Often requires coordination across regulatory centers (e.g., CDER + CDRH)
- Submission planning is more complex and may need early agency input
Diagnostics and IVDs
Typical submissions: 510(k), PMA (U.S.); IVDR (EU)
What’s unique:
- May follow device regulations, but new rules (like IVDR in Europe) add complexity
- Analytical and clinical performance data are key
- Software-driven IVDs may need additional cybersecurity or AI-related documentation
ATMPs, Biosimilars, and Other Specialized Categories
There are other fast-growing or niche categories (like cell & gene therapies, biosimilars, or veterinary products) that follow their own regulatory pathways. These often involve even greater documentation complexity, regional variability, and evolving guidelines.
No matter what type of product you’re working on, the core submission principles apply, but understanding what’s expected for your specific category is essential to building the right submission strategy, timeline, and team.
RIM: Your Regulatory Backbone
The regulatory submission process has a lot of moving parts, and the more products, partners, or markets you’re managing, the more complex it gets.
That’s why a great RIM system isn’t just a nice-to-have. It’s the regulatory backbone supporting you through the entire journey.
From mapping out submission plans and tracking timelines, to keeping documents organized, approvals on schedule, and post-submission commitments visible, a good RIM platform keeps everything (and everyone) moving in the same direction. It gives you confidence that nothing’s slipping through the cracks, even when you’re juggling multiple submissions at once.
At Kivo, we’ve built a RIM system that does exactly that without the complexity or cost of traditional enterprise tools. It’s fast to implement, easy to use, and purpose-built for life sciences teams that want to work smarter, not harder.
If you're curious to see how it works, we’d love to show you. Click below to book a demo and chat with our team of life sciences specialists.
