Regulatory Operations & Regulatory Systems

Let our eCTD experts manage, prepare and submit your regulatory submissions and dossiers to global health authorities. Whether you're preparing your first IND or well into maintenance submissions, we can help.

A compliant submission starts at the ground level with documents that are ready to submit according to regulatory authority guidance and best practices. Let us streamline your submissions by ensuring your PDFs are bookmarked, hyperlinked and optimized for submissions.

Every company's needs and milestones are different when it comes to submission strategy. When it's time to gear up for your IND, CTA or NDA/BLA, we can help you develop a strategy that keeps your company's needs, milestones, and timelines in mind while ensuring regulatory compliance.

Need help fixing a Word document whose formatting has gone rogue? Looking to convert an IMPD into eCTD-ready CMC documents? We can help ensure your documents are clear, consistent, and prepared for submission readiness activities.

We can maintain your product lifecycle with our decades of regulatory operations expertise to ensure regulatory compliance coupled with your preferred validated eDMS for review, approval, eCTD publishing and archival.

We can help you develop ready-to-use templates — whether it's CMC documents, annual report templates, or custom solutions for whatever your company needs.