Services

We offer a wide range of services relating to pre-IND planning and development. While this is our core focus, we are also excited to support clients in adjacent areas of drug development and regulatory compliance. Whether you're navigating early-stage strategy, document preparation, or operational compliance, we’re here to help guide your path.

Pre-IND Regulatory Strategy and Planning

Pre-IND meeting preparation & FDA briefing document guidance.

Regulatory development roadmap (nonclinical, CMC, clinical).

Gap analysis for early-stage drug development plans.

Strategic advice on FDA expectations and timeline alignment.

Regulatory Document Review & Compliance Audits

IND and pre-IND submission document reviews (format, structure, compliance).
eCTD readiness assessments (format, validation, module alignment).
Review of Investigator Brochures, protocols, study reports, etc.
FDA guidance alignment checks.

Standard Operating Procedures (SOPs) & Policy Development

Drafting or reviewing SOPs for GxP (GLP, GMP, GCP) compliance.
Regulatory operations SOPs (e.g., for submissions, archiving, quality systems).
Internal compliance checklists and templates for emerging biotech companies.

Service Packages

eCTD Compliance, Pre-IND FDA Meeting Strategy and CMC compliance.

 

  • Draft the Pre-IND meeting request letter, the initial questions for FDA, and outline/author the briefing package (including summaries of nonclinical, CMC, and clinical sections).

  • Review and guidance for eCTD compliance.

  • CMC compliance planing for the IND.
  • Other areas as requested.

  • 1-hour prep call with scientific team.

IND Module Planning & Authoring Framework

 

  • Review IND with respect to data gaps in nonclinical (Module 4) and CMC (Module 3).

  • Draft core elements of Module 1 (cover letter, forms, intro statement).

  • Draft Module 2 summaries: 2.4–2.7 (intro to summaries, quality/clinical/nonclinical).

  • Create master document control SOP.

  • Review and guidance on eCTD compliance.

  • Other areas as requested.

SOP Development & Readiness Assessment

 

  • SOP gap analysis with respect to GLP for nonclinical, GCP for clinical planning.

  • Create or revise 5–10 SOPs (e.g., document control, training, study archiving, monitoring plans).

  • “Compliance Readiness Snapshot” report.

  • Checklist for FDA inspection triggers (including sponsor responsibilities).

  • Training session on GLP vs. GCP principles.