Regulatory Submissions Services: Ensuring Success Across IND, NDA, BLA, and MAA
Your regulatory submissiontimeline depends on how well writing, submissions, operations, and cross-functional coordination come together. We bring the structure and expertise to keep your program moving through critical milestones.
More than producing documents, we're helping move your program forward.
End-to-end support
Coordinated writing, operations, and submission leadership
Global regulatory submission expertise
Experience across FDA, EMA, and international agencies
Integrated teams
Seamless collaboration across functions and stakeholders
Faster timelines
Structured processes that reduce delays and rework
How It Works
However much support you need, one workstream or the whole program, here's how we move a submission forward:
We start with the plan
Timelines get mapped, and writing, operations, and cross-functional teams start working from the same page instead of separately.
Writers take it from there.
Clear, compliant documentation across clinical, nonclinical, CMC, and beyond.
Nothing moves forward without QC
Every document gets checked and formatted before it advances, catching the kind of issues that normally turn into late-stage rework.
Operations handles the technical side.
eCTD publishing, validation, and submission management, so the paperwork matches the science.
We lead through major milestones
Our team coordinates IND, NDA, BLA, MAA (just to name a few) so every workstream lands together, not in pieces.
It doesn't stop at filing.
Global disclosure requirements, aggregate safety reporting, we stay in it.
Veristat Expertise
30+ years of science-first drug development, across every market, every modality.
Therapeutic nuance, not templates
Regulatory writing isn't one-size-fits-all, and treating it that way shows. We write with the depth your therapeutic area actually requires.
Fluent in plain language.
Lay summary and plain-language requirements have reshaped what "clear" documentation means. Our team already writes for that world, work that holds up with regulators and makes sense to patients.
Built for complexity.
Rolling submissions, shifting deadlines, high-volume workstreams, that's usually when the work gets more interesting to us, not less. Our process holds up under pressure without cutting corners on quality.
Scalable by design.
Whether it's a single document or an entire submission, we scale to match the scope, without losing the coordination that keeps everything moving together
Complex submissions, including rolling BLAs, delivered on schedule as timelines shift
Veristat's Offerings
End-to-End Support Across the Submission Lifecycle
Regulatory Strategy & Consulting.
Expert guidance across the development lifecycle, including global regulatory strategy, development and submission pathways, regulatory roadmaps, gap analyses, and accelerated or expedited pathways.
Health Authority Strategy & Agency Engagement.
Strategic preparation and support for FDA, EMA, and other global health authority interactions, including briefing packages, scientific advice, pre-submission meetings, and formal agency meetings.
Clinical Development Regulatory Support.
Regulatory strategy and documentation for INDs, CTAs, IMPDs, protocols, clinical development plans, study design, endpoints, labeling, and related development activities.
CMC & Nonclinical Regulatory Support.
Regulatory strategy, gap assessments, document review, and writing support for CMC and nonclinical content across clinical development and marketing applications.
Regulatory & Medical Writing.
Clear, compliant documentation across clinical, nonclinical, CMC, and safety disciplines, including protocols, investigator brochures, clinical study reports, CTD modules, briefing packages, and responses to health authority questions.
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Submission Strategy & Leadership.
End-to-end strategic planning, oversight, and cross-functional coordination for IND, CTA, NDA, BLA, MAA, NDS, and other global regulatory submissions.
Marketing Applications & Registration.
Strategic and operational support for marketing applications, including content development, authoring, project management, submission preparation, registration, and indication extensions.
Regulatory Operations & Publishing.
Submission planning and coordination, eCTD publishing, technical compliance, validation, submission management, and regulatory lifecycle management.
Document Quality & Management.
Full or targeted QC, formatting, document-level publishing, and submission-readiness support for sponsor- or partner-authored documents.
Clinical Disclosure & Transparency.
Global trial registration, results posting, anonymization, transparency, and disclosure support, including ClinicalTrials.gov and CTIS requirements.
Regulatory Designations & Special Pathways.
Strategy and preparation for Orphan Drug, Fast Track, Breakthrough Therapy, RMAT, PRIME, ILAP, pediatric plans, and other specialized regulatory pathways.
Safety & Pharmacovigilance.
Aggregate safety reporting, risk management plans, safety documentation, and regulatory support across the product lifecycle.
Medical Affairs & Scientific Communications.
Scientific and medical communications support that translates complex evidence into clear, scientifically rigorous materials for relevant audiences.
Clear, Inclusive, Human: The Lay Language Shift Reshaping Clinical Communications
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Delivered a rolling BLA submission ahead of schedule despite shifting timelines
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Best Practices for Safety Narrative Writing in Clinical Research
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Meet our experts
Sarah Hopwood
Vice President, Global Medical Writing
Heather Graham
Vice President, Regulatory Science & Medical Affairs
Steve Sibley
Vice President, Regulatory Strategy
Evan Richardson
Senior Director, Clinical Disclosure
Daphne Smyth
Vice President, Global Regulatory Affairs
What's Next in the Drug Development Process
Agency Meetings
Prepare for and navigate FDA, EMA, and other regulatory agency interactions.
Chemistry, Manufacturing, and Controls (CMC)
Build the manufacturing and analytical strategy your submission requires.
Regulatory Consulting.
Get deeper support on program-level regulatory strategy and trial design.
Biometrics
Ensure your data is submission-ready and standards-compliant before it reaches the agency.
Turn finalized data into a submission-ready story.
Database lock is a milestone, not the finish line. Veristat brings regulatory writing, submission strategy, operations, and cross-functional expertise together to turn your finalized data into a cohesive regulatory story, keeping every workstream aligned as your program moves toward filing and regulatory review.
Share where your program stands, and one of our regulatory strategists will follow up.
Regulatory writing support spans documentation across the full submission lifecycle, including clinical, nonclinical, and CMC writing, submission leadership for IND, NDA, BLA, and MAA milestones, clinical disclosure and transparency, regulatory operations like eCTD publishing, safety and pharmacovigilance documentation, and document quality management.
Sponsors typically engage regulatory writing support at critical points where timelines tighten and coordination gets complicated, such as approaching database lock, managing high-volume writing across multiple workstreams, preparing for major regulatory milestones, or needing to scale quickly without sacrificing quality.
In-house writing works well for many programs, and this doesn't have to be all-or-nothing. Where outside support tends to reduce risk is at the points where timelines tighten or workstreams multiply, when a document backlog threatens a milestone date, or when a specialized area like lay-language summaries or global disclosure requirements falls outside your team's day-to-day experience. Bringing in targeted support at those moments helps catch issues before they turn into late-stage rework or a missed submission date, without requiring you to hand over the whole process.
Both. Sponsors can bring in targeted expertise for a specific workstream, such as document QC or eCTD publishing, or rely on full program ownership spanning writing through submission leadership, depending on what the program needs.
Veristat supports global compliance needs including clinical disclosure, anonymization, and transparency requirements, alongside submission experience across FDA, EMA, and other international regulatory agencies.
