CMC & Regulatory Strategy
De-risking the path to IND and NDA approval
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Regulatory success isn't just about filling out forms; it's about telling a consistent, scientific story that proves your drug is safe and reproducible. We help pharmaceutical and biotech companies navigate the complex maze of FDA/EMA expectations.
We specialize in "Phase-Appropriate" strategies—ensuring you do enough to ensure safety and compliance at the earlier stage, without wasting capital for the later stage requirements before you have clinical proof-of-concept.
Our Technical Capabilities
Our Technical Capabilities
Strategic Planning & Gap Analysis
Strategic Planning & Gap Analysis
Before we write a single page, we define the roadmap. We align your CMC activities with your clinical timeline to prevent critical path delays.
Regulatory Roadmap: Defining the exact studies required for IND, clinical phases, and NDA.
Gap Analysis: Identifying missing data or compliance risks in your current package.
Meeting Prep: Strategy and CMC part of briefing books for Pre-IND and End-of-Phase (EOP) meetings with the FDA.
Medical Writing & Submission (Module 3)
Medical Writing & Submission (Module 3)
We transform raw data into persuasive regulatory arguments.
IND/IMPD Authoring: Writing clear, defensible Quality sections (Module 3.2.S) for early-stage filings.
NDA/MAA Preparation: Managing the massive data compilation required for marketing applications.
Response to Questions: crafting scientific responses to Agency Information Requests (IRs) to keep your review on track.
Risk Management & Control Strategy
Risk Management & Control Strategy
We build quality into the process using data, not guesswork.
Specification Setting: Establishing phase-appropriate acceptance criteria.
Impurity Strategy: Managing genotoxic impurities (mutagenic), elementals, and solvents per ICH guidelines.
Risk Assessment: FMEA and risk mitigation tools to satisfy "Quality by Design" expectations.
The "HIL" Difference
The "HIL" Difference
"Phase-Appropriate" Means Capital-Efficient.
"Phase-Appropriate" Means Capital-Efficient.
Many consultants apply "Big Pharma" standards to Phase 1 startups, burning cash on unnecessary studies. Others cut corners, leading to Clinical Holds. At HIL CMC Consulting, we know the sweet spot. We build strategies that satisfy the regulators' safety concerns now while building a foundation for commercialization later.
Typical Outcomes
Typical Outcomes
Accelerated Filing:
Moving from "Data Available" to "Submission Ready" in weeks, not months.
No Clinical Holds:
Preventing the 30-day delays caused by preventable CMC quality issues.
Agency Trust:
Building a reputation for high-quality submissions that make the reviewer’s job easier.
Robust Data Packages:
Creating a "clean" regulatory history that adds value during partner due diligence.
When to Engage
When to Engage
Pre-IND:
When you are 6–12 months away from filing and need to define your starting material and impurity strategy.
Clinical Phase Transitions:
Moving from Phase 1 to Phase 2, where compliance expectations tighten significantly.
Pre-NDA:
When you need a "Mock Inspection" of your data package before the final submission.
Explore Other Services
Explore Other Services
Looking for more? Explore our other core capabilities:
Looking for more? Explore our other core capabilities:
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