Compliant and compelling filings, every time.
The Harmony Biotech team combines scientific rigor with regulatory insight to guide interactions with FDA, EMA, and other global agencies, ensuring your filings are complete, compliant, and compelling. Whether you're preparing a pre-IND briefing, responding to a clinical hold, or building a BLA or RMAT request, we help you anticipate challenges and align your approach with evolving expectations.
How we work
Our regulatory experts operate as integrated extensions of your development team, preparing for each engagement by mapping agency expectations against your current data. We help you ask the right questions, frame your narrative strategically, and build submissions that accelerate clinical readiness. We offer flexible, full-scope support that includes:
Strategic planning for IND, NDA, BLA, CTA, and accelerated pathways
Briefing package development and meeting coordination with FDA and EMA
Application authoring and eCTD publishing for preclinical, clinical, and CMC modules
Risk-based strategies for clinical hold resolution, expedited designations, and inspection readiness
Case Study
Lifting a clinical hold through EMA strategy
A clinical-stage biopharma company developing a novel small molecule faced a clinical hold from the EMA due to misalignment between the proposed dosing regimen and supporting nonclinical data. Harmony helped refine the data presentation, recommended protocol adjustments, and led scientific dialogue with EMA reviewers.
Clinical
hold lifted
Trial cleared to proceed on schedule
Regulatory standing strengthened in the EU
VP, Regulatory Affairs
Monoclonal Antibody Company
"Harmony's regulatory experts brought a depth of experience and strategic insight that proved invaluable during our BLA review. Their ability to anticipate FDA questions, mitigate potential issues, and align our submission with regulatory expectations positioned us for success. Their guidance was instrumental in navigating a complex review process and securing BLA approval."
FAQ
A well-structured pre-IND meeting is a pivotal opportunity to de-risk your development program and align early with FDA expectations. Key focus areas should include:
- Nonclinical Program Adequacy: Confirm that your toxicology and safety pharmacology studies are appropriate to support first-in-human dosing.
- Clinical Protocol Design: Seek feedback on your proposed Phase 1 protocol, including dose selection, patient population, safety monitoring, and study endpoints.
- CMC Readiness: Discuss the manufacturing process, control strategy, and analytical methods-especially those related to product identity, purity, potency, and safety.
- Data Sufficiency: Clarify the expected data package needed to support IND acceptance and progression into clinical trials.
Harmony ensures that your pre-IND briefing package asks the right questions, anticipates regulator concerns, and positions your program for a successful IND submission.
Breakthrough Therapy, RMAT, and Fast Track designations are powerful tools for accelerating development-but securing them requires more than strong data. Regulatory authorities are looking for a clear demonstration that your product has the potential to offer substantial improvement over existing therapies for serious conditions.
To be successful, your request must combine robust scientific evidence with a strategic narrative that clearly articulates the product's value, the unmet medical need it addresses, and the clinical significance of your findings.
Harmony has extensive experience preparing successful Breakthrough, RMAT, and Fast Track submissions. We help clients across modalities build persuasive, data-driven applications-integrating clinical and nonclinical results with regulatory insight to maximize impact. We also support pre-submission strategy, FDA engagement, and communication planning to ensure your request is well-positioned from the outset.
FDA inspections can be successfully navigated with proactive preparation, structured execution, and strong internal alignment. This means establishing an inspection management framework that ensures both readiness and control.
Key preparation steps include:
- Conducting a mock FDA inspection to identify potential gaps in documentation, systems, and practices-ideally led by third-party experts with FDA-facing experience.
- Establishing a centralized "war room" with trained subject matter experts (SMEs), real-time document control, and coordinated communication protocols.
- Training staff on inspection behavior, response etiquette, and key messages.
- Preparing documentation in advance, ensuring quick access to SOPs, batch records, CAPAs, deviation reports, and validation data.
During the inspection, it is critical to provide clear, accurate answers and proactively address any regulatory concerns. Post-inspection, a timely and well-documented response to 483 observations-or any informal findings-is essential to maintain compliance and credibility.