GRA Pharma Consulting
GRA Pharma Consulting

Our Mission

Our MissionOur MissionOur 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 

Discover What Our Clients Love

Contact Us

GRA Pharma Consulting

Lexington, MA 02421, USA

hello@grapconsulting.com

Hours

Open today

09:00 am – 05:00 pm

Drop us a line!

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