Regulatory Operations

Your pathway to seamless submissions

At inSeption Group, our Regulatory Operations team brings together specialized expertise, advanced technology, and seamless collaboration to get your submissions right—the first time. Whether it’s an Investigational New Drug (IND) application, a New Drug Application (NDA), or a Biologics License Application (BLA), we help you accelerate timelines, ensure compliance, and alleviate the burden of navigating complex submissions.

A seamless collaboration

We know the value of placing the right people in the right roles. Our RegOps team collaborates closely with Regulatory Affairs, authors, and stakeholders from the start, ensuring every document is formatted, published and submitted according to evolving regulatory requirements.

Full-service RegOps support

We handle every detail of your regulatory submissions—from planning to execution—to ensure approval of your applications:

  • Knowledge of global standards, including 21 CFR Part 11 and ICH guidelines
  • Proficiency in eCTD, non-eCTD submissions, and ESG Gateway
  • Comprehensive formatting and publishing of all eCTD modules
  • Efficient and seamless coordination of Clinical Study Report preparation and assembly
  • Advanced Skills in MS Word, Adobe Acrobat, EDMS, document authoring templates, and publishing systems

Strategic optimization for long-term success

We go beyond execution with consulting and process improvement support:

  • Gap analyses to identify areas for streamlining
  • Tool evaluations and system recommendations
  • Workflow optimization to reduce rework and risk

On time. On target.

Every submission matters. That’s why our RegOps team acts with speed, care, and attention to detail, ensuring your applications are accurate, compliant, and on time—every time.

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