Regulatory.Policy.Science.Strategy.
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Our Services

We are leaders in the field of
Complex and Natural Product Development

HG offers services to the industries regulated by the United States and Canada.
 
Our services span the development process from product conception and target analysis, nonclinical, clinical, and post-marketing strategies.  
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We review, assess and actively manage the raw material, nonclinical, clinical, regulatory processes. We conduct compliance assessments regarding "GXPs". 
What we do: 
  • Audits, compliance - GACP, GMP, GCP
  • Dossier Assessment and "Gap" Analysis
  • Intellectual Property Strategies
  • Investor Interface
  • Clinical Strategies
  • Laboratory & Manufacturing Linkage
  • Medical Writing
  • Monitoring Nonclinical and Clinical Trials
  • Protocol development, writing, review
  • Raw Material vendor identification and evaluation
  • Regulatory Interactions and Communications
  • Resource Identification and Liaison (CROs, CMOs, Contract Labs, etc.)
  • US Agent (development clients only)​

We specialize in:

  • Animal Derived Products
  • Ayurvedic medicines
  • Botanicals
  • Complementary Alternative Medicines
  • Complex drugs 
  • Fish & Marine Oils
  • Food and Dietary Ingredients
  • Live Biotherapeutics
  • Natural Products
  • Probiotics
  • Traditional Medicines: TCM, Kampo
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