Regulatory Affairs

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Regulatory Affairs

Nor Consult will partner with your regulatory affairs consultants and attorneys to develop a clinical development strategy that is most likely to achieve the broadest possible indication approvals for your investigational product. We have long-standing relationships with key regulatory consultants that we can leverage to our your advantage.

Submissions

Trust our expert knowledge of global regulations more»

Legal Representation

The use of medical professionals in legal cases has become an increasingly important more»

Medical Writing

Documents involved in each stage of the clinical trial must be prepared at the highest level more»

Regulatory Submissions

Trust our expert knowledge of global regulations concerning device, drug and combination products to ensure that your trial design is appropriate for the target regulatory agency. Nor Consult has designed and managed trials with recruitment efforts in Asia-Pacific, Europe and North America.

  • FDA
  • TGA
  • Health Canada
  • European national competent authorities
  • Local and central ethics committee submissions
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Legal Representation

The use of medical professionals in legal cases has become an increasingly important and common occurrence. Medical professionals are unbiased expert witnesses who provide scientifically sound testimonies in support of your case. At Nor Consult, LLC, our team of medical specialists are ready to be your liaison in legal cases. Ask us about our successful history of prior representations.

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Medical Writing

Documents involved in each stage of the clinical trial must be prepared at the highest level of accuracy, in a timely manner, and in strict adherence to federal guidelines as well as GCP guidelines. From composing abstracts to developing complex statistical analysis plans, our team of medical writers ensures that all documentation related to your clinical trial meets the requirements and expectations set forth by journals and regulatory agencies.

Nor Consult, LLC, can prepare the following at your request:

  • Clinical Study Protocols / Clinical Investigation Plans
  • Informed Consent Forms
  • Investigator Brochures
  • Investigator Newsletters
  • Literature Reviews
  • Clinical Study Reports
  • Clinical Evaluations Reports (CERs)
  • Safety Reports
  • Statistical Analysis Plans
  • Case Report Forms
  • Manuscripts
  • Risk Management Plans
  • Abstracts
  • Posters
  • Technical Reports
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