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Regulatory Affairs

Commercialisation of a therapeutic product relies on obtaining marketing clearance from the relevant Regulatory authority in the country that is the target of the company's marketing push.

 

We can assist you in commercialising your therapeutic product through:

 

  • Strategic planning for obtaining regulatory listings or certifications in your target markets.
  • Experience in obtaining regulatory listings and certifications for medical devices in the following regulatory jurisdictions:
  • •  Australia (Therapeutic Goods Administration, TGA).

    •  The United States of America (Food and Drug Administration, FDA).

    •  The EU (CE Mark).

    •  Canada (Health Canada ).

    •  New Zealand (Medsafe).

    •  Singapore (HSA).

    •  Thailand ( Thailand FDA).

  • Liaison with regulatory authorities.
  • Implementing a comprehensive postmarket vigilance and adverse incident reporting program.
  • Assessing compliance against the Essential Principles (TGA) and the Essential Requirements (EU) for your product's quality, safety and performance.

Our Experience

Our regulatory experience has assisted a number of companies in the commercialisation of their products, including companies producing:

  • sterile, implantable medical devices;
  • software-driven medical devices;
  • OTC medications;
  • device/biologic combination;
  • biologics; and
  • active medical devices.