Regulatory Operations

 
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Expert guidance. Seamless execution. Confident submissions.

Electronic regulatory submission requirements are complex. However, they don’t have to stand between your product and the patients who need it most. With Innomar by your side, you gain expert guidance backed by years of experience. From pre-meeting requests to NDAs (U.S.) and NDSs (Canada), and through post-marketing requirements, we help you move forward with clarity, confidence, and peace of mind.

We handle every detail under one roof — reducing handoffs, minimizing delays, and ensuring continuity. With our integrated approach, you’ll save time, reduce stress, and reach the market faster.

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What we do

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We offer a full range of regulatory operations services, tailored to your needs:

  • Document-level publishing 
  • All Electronic Common Technical Document (eCTD) submissions to Health Canada and  FDA 
  • Non-electronic Common Technical Document (NeeS) submissions  
  • Public Release of Clinical Information (PRCI) for pharmaceuticals and medical devices 
  • XML Product Monographs (XML PM)  
  • Structured Product Labelling (SPL) 
    • Establishment registrations
    • Drug product listings
    • National Drug Code (NDC) requests
    • No change notifications, etc.

 Additional offerings:

  • ASCII datasets creation/conversion
  • Carton and container labelling artwork (creation and manipulation)
  • Creation and electronic submissions to NNHPD (we are a registered trading partner)
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I continue to rely on all of your very professional expertise and very much appreciate it...It continues to be my pleasure to work alongside each and every one of you!

Client testimonial

Why Innomar?

Expertise that accelerates success

We help clear your way with a nuanced understanding of regulators’ standards. Our deep experience working with Health Canada and the FDA informs our approach, whether you’re preparing an IND, NDA, NDS, DNF, or other regulatory submission. It’s how we anticipate challenges, streamline the review process, and make your path to market as efficient as possible — so you can focus on advancing patient care.

Built-in value

Successful submissions require both specialized software and experienced professionals — resources that can come at a significant annual cost. When you partner with Innomar, you gain access to both with our comprehensive service offering. Our expert team helps ensure your submission is right the first time, reducing delays, rework, and costly setbacks.

Responsive and reliable

Your timelines are tight. That’s why we prioritize fast, clear communication and exceptional customer service. So you stay on track without compromising quality.

Preparing for the future

The regulatory landscape is always evolving, but with Innomar, you’ll stay ahead. Our team is ready for changes like eCTD 4.0, working with trusted software partners to ensure you meet tomorrow’s standards with confidence.

Our commitment

  • Integrity and ethics: We uphold the highest standards for every submission
  • Compassion and care: We understand the impact our work has on patients’ lives
  • Adaptability: We evolve with your needs and the regulatory environment
  • Dedication:  We see every project through with focus, efficiency, and precision

End-to-end solutions

The journey to bring complex or innovative therapies to market requires a partner who is laser-focused on the requirements for a strategic launch and operationalizing throughout the product lifecycle. We use our deep industry knowledge and network of connections to help you to plan and execute your commercialization strategy.
Just wanted to reach out to say thank you for your support of the [product] NDS. Very exciting to be able to get this across the finish line according to our timelines. Appreciate your support.

Client testimonial

Your product’s success starts here

You’ve worked tirelessly to develop your product. Don’t leave its success to chance. With Innomar, you’ll simplify complexity and achieve high-quality results that meet industry standards.

Ready to get started?

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