Global Regulatory Affairs Strategy Development & Submissions

The Food and Drug Administration (FDA) and European Medical Agency
(EMA), as well as other regulatory agencies throughout the globe have product
commercialization requirements that continue to evolve quickly. In the US
market, three specific areas from FDA’s perspective are the evolution of biosimlar product regulation, 510(k) premarket notifications and use of social media tools for promotion.  tJun17 Life Sciences will help you to understand current global regulatory guidelines to maximize your chance for product approval and minimize time to peak sales.  In addition, we can support you in your submission of regulatory applications and documentation to a wide array of regulators and other stakeholders.

Examples of work we have led or supported are listed below:

Global Submissions, including Pre-market Approvals (PMA’s), 510(k) Premarket Notifications, Biologics License Applications (BLA’s), CE-mark Certifications, Brazil ANVISA applications, and Submissions to Health Canada and the Australian Therapeutic Goods Administration (TGA)

  • Single and multi-use viscosupplementation products for treatment of osteoarthritis – US, EU, Turkey
  • An anti-LPS monoclonal antibody for treatment of gram negative sepsis – US
  • An HIV-1 genotyping kit used to detect potential resistance to antiviral drugs – US, Europe and Canada
  • A medical device utilized in hand-assisted laparoscopy – US, Europe, Australia
  • A medical device system utilized to morcellate intrauterine fibroids and polyps – both individual components and system – US, Europe, Canada, Australia
  • A medical device system utilized to resect peripheral varicose veins – US, Europe, Brazil
  • A medical device utilized for soft tissue fixation in ACL reconstruction surgery – US, Europe, Canada
  • A medical device utilized to protect soft tissue grafts during ACL reconstruction surgery – US, Europe, Canada
  • An RF based medical device utilized for soft tissue ablation applications in the spine – US, Europe
  • A biopolymer based matrix utilized in cartilage repair applications – US, Australia

Give us a call if you would like to discuss further.  Redacted writing samples for each of these submissions are available upon request.