Belsyme Regulatory Consulting
PHARMACEUTICAL AND MEDICAL DEVICE REGULATORY AFFAIRS CONSULTING
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Pharmaceuticals

 

Pharmaceuticals 

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Belsyme has specialist regulatory knowledge in the development of regulatory strategy, initial product registration and life cycle management of:

  • Prescription Medicines,

  • Biological Products

  • Generic Medicine

  • OTC

for the Australian and New Zealand markets. Belsyme has Comprehensive knowledge of the Australian Therapeutic Goods Administration (TGA) and New Zealand Medicines and Medical Devices Safety Authority (Medsafe) regulatory agencies. Belsyme is currently on a number of TGA industry workings and Association forums. 

 

 

Belsyme offers the full range of regulatory consultancy services that includes but is not limited to:

  • Regulatory Strategy Development

  • Preparation and Submission of New Product Registrations ie Category 1 Applications Prescription Medicine Streamline Submission process and New Medicine Application (NMA) and Abridged NMA (Generic and Proprietary)

  • Agency meetings and Liaison

  • Labelling and Product Information/ Datasheet creation and management

  • Preparation and submission of variation submission ie: Category 3, Changed Medicine Notifications, S14 exemptions, Response to Requests for Information (S31 Requests)

  • GMP Applications

  • Export Listing Applications

  • Certificates of Pharmaceutical Products

  • Drug Shortage Management

If you would like more information on any of our services please feel free to contact us.