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Regulatory Affairs Consulting

Our Regulatory Affairs consultants ensure that your company complies with relevant regulations and laws, liaises with regulatory agencies (such as FDA) and internal teams on specific issues pertaining to drug/device development, and leads cross-functional teams to develop regulatory submissions (IND, NDA, etc.)

BioBridges Regulatory Affairs consultants typically function in these areas:

  • Strategic consulting
  • Coordinate registration and licensing activities
  • Manage and ensure compliance with reporting requirements
  • Technology transfer and asset integration
  • Labeling development and review
  • Regulatory operations support
  • Regulatory project management
  • SOP/Work instructions for regulatory activities

Contact Us
For help managing your next clinical trial, contact BioBridges today.

    At BioBridges, we have highly skilled consultants with extensive experience in the biotech, pharmaceutical, and medical device industry. With a wide range of expertise, these life science consultants are incredibly well suited to step in and immediately provide valuable contributions to your development programs. Whether you are an emerging start-up or an established company, looking for individuals or functional teams, BioBridges' consultants provide guidance and support to accomplish the objectives across all areas of clinical development. You can accomplish the work with experienced professionals whose passion is to focus on programs that inspire them, move important work forward, and make an impact. Engaging BioBridges gives you the ability to accomplish the work at hand.

    Over the past few years, I have been contacted by an number of agencies regarding projects. Most turn out to be “black holes” where I submit a resume and never hear anything back. BioBridges has reached out to me with a number of opportunities. I am now working with a gene editing company who plans to file their first IND later this year. I appreciate all of the attention and guidance I receive from BioBridges, and highly recommend them.

    William Heydon

    | BioBridges Professional