Our Mission
Support our partners in navigating the evolving landscape of regulatory science to deliver innovative products to patients
About GRA Pharma Consulting
About Our Consultant
- Dahua Pan is the lead regulatory consultant at GRA Pharma
- Dahua (Daniel) Pan | LinkedIn
- Regulatory Experience:
* In-depth knowledge of pharmaceutical product development
* Major regulatory filings/activities – IND/CTA, NDA/MAA
* Extensive FDA meeting experience: pre-IND, EOP2, Type A/B/C/D and AdCom meetings
* Broad interaction with global regulators including EMA, BfArM, MHRA and PMDA - Therapeutic area experience: cardiology, neurology, oncology, hematology, nephrology, ophthalmology and metabolic diseases
- Drug modality experience: gene/cell therapy, biologics, oligonucleotides and small molecules
Services
- Develop regulatory strategy
- Lead and prepare team for Health Authority interactions
- Manage and oversee regulatory submissions including IND, CTA, NDA/BLA, and MAA
- Support the partner's corporate strategy and business plan
Selected Projects
Startup/Small Company Support
Guide, through a detailed step-by-step process, a small company through its first pre-IND process and IND preparation for a complex gene therapy/drug/device combination product
Global Vision
Lead the development of global strategy to support accelerated development
Case 1: Initiate Phase 2 in the US using China IIT data
Case 2: Initiate Phase 3 in the US using ex-US Phase 1 data
Innovative Approach
Utilize Real World Evidence from a registry to achieve full approval in lieu of a confirmatory trial
Extensive FDA Experience
Lead multiple FDA meetings to align on a clinical strategy that mitigate enrollment challenges in a rare disease
Regulatory Program Management
Oversee global clinical trial submission in 25+ countries including EU-CTR