Medical Writing & QC

Your submission success story starts here

At inSeption Group, we know that the quality of your regulatory documentation can define the success of your trial. That’s why we’ve built a team of expert medical writers, QC professionals, and project managers who collaborate seamlessly to deliver precise, compliant, and submission-ready documents.

inSeption’s recipe for success: the right people, paired with continuity

It’s easy to say. Everyone says it. Every CRO claims to have the right people, but at inSeption, we live by it. We believe that corporate memory and expertise reside in people—not platforms, not processes. That’s why we prioritize continuity and hands-on leadership, ensuring our experts become an extension of your team.

This powerful synergy creates unmatched cost and operational efficiencies for our sponsors.

We don’t just write, edit, and revise—we lead, problem-solve, and execute with precision. When our people take personal ownership of your success, the outcome becomes more predictable, more impactful, and more aligned with your goals.

Sometimes, we wish it was something flashier. It’s not.

We build trust by doing exactly what we say we’ll do.

This is integrity. This is inSeption. When our clients succeed—we succeed.

Comprehensive project management

Regulatory writing is more than just writing—it’s about execution. At inSeption, our project managers keep everything on track so you don’t have to:

  • Creating and enforcing timelines
  • Facilitating document reviews
  • Coordinating with publishing teams
  • Managing comment reconciliation meetings

By handling the entire process, we alleviate administrative burden, ensuring you never have to hire another company to manage timelines and logistics.

Strategic planning for success

Every successful submission starts with a strong foundation. We build in strategic efficiencies from the start, including:

  • Integrated style guides and harmonized terms for consistency across documents
  • Robust document blueprints to align stakeholders early
  • Early data reviews to avoid last-minute surprises
  • Senior leadership engagement at critical decision points

Our proactive approach eliminates rework, prevents bottlenecks, and ensures first-time quality submissions.

Seamless team engagement

Successful submissions rely on clear communication and team alignment. We foster high-functioning, engaged teams by:

  • Aligning shared values and expectations
  • Maintaining concise, transparent communication
  • Holding daily stand-ups and regular status updates

We don’t just keep the process moving—we make your team stronger, offering customized training, management, and team-building support through our Cooperativity Program

Specialized knowledge and skills

Our medical writers and consultants bring deep expertise in niche therapeutic areas, including:

  • Rare/orphan diseases
  • Neurodegenerative diseases
  • Gene therapy
  • Cell therapy
  • Oncology

Have a different focus area? We’ve supported a broad range of therapeutic areas. Contact us to explore how our experience aligns with your needs.

Comprehensive medical writing services

Our medical writing team specializes in creating a wide range of critical regulatory and scientific documents within the following areas:

Global regulatory submissions:

Modules 1, 2, 4, and 5 of NDAs, BLAs, and MAAs:

  • Nonclinical Summaries and Overview
  • Clinical Summaries and Overview
  • Label support

Orphan Drug Applications

Investigational New Drug (IND) applications

Modules 1, 2, 4, and 5:

  • Nonclinical reports
  • Nonclinical Summaries and Overview
  • Clinical Summaries and Overview

Investigator’s Brochures
IND-enabling competencies

Clinical study reporting:

Clinical Protocols and Amendments

Clinical Study Reports:

  • Phase 1-4
  • Abbreviated, synoptic, addenda
  • Safety Narratives

Public disclosures:

  • Postings for clinicaltrials.gov and EudraGMPD
  • Lay summaries

Regulatory agency and health authority interactions:

  • Briefing Books (all types)
  • Responses to agency questions
  • Pediatric Study Plans and Pediatric Investigation Plans

Nonregulatory medical and scientific communications:

Publications:

  • Manuscripts
  • Abstracts
  • Posters

Uncompromising quality control

Our Quality Control (QC) experts ensure every document meets the highest regulatory and scientific standards through:

  • 100% QC of all documents
  • Verification of consistency across all documents
  • Detailed reviews for regulatory accuracy

Let’s write your story together

When you work with inSeption Group, you gain more than a service provider—you gain a true partner. Our team is dedicated to precision, efficiency, and delivering top-quality regulatory documents—on time, every time.

Dive deeper

Schedule quality time today.