Regulatory Affairs

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Regulatory Affairs

There are major differences in the way clinical trials are designed and executed for drugs compared to those for medical devices. At Nor Consult, LLC, our team implements meticulous strategies to address those differences when preparing and submitting your drug or medical device clinical trial application for approval. Our policy is to always be our clients' reliable guide and partner in compliance.

Submissions

Based on the classification of the device or type of drug, and the region 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

Based on the classification of the device or type of drug, and the region in which the clinical trial will be taking place, different strategies are required for the submission and approval stages. At Nor Consult, LLC, our highly skilled personnel have expert knowledge of global regulations concerning device and combination product research. Our experience in managing trials that report to the FDA, Health Canada, the TGA, and other regulatory bodies ensures a seamless transition from trial application to enrollment. Nor Consult, LLC, provides regulatory services for the following reporting agencies:

  • 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 Institutional Review Board requirements. 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
  • Informed Consent Forms
  • Investigator Brochures
  • Investigator Newsletters
  • Literature Summaies
  • Clinical Study Reports
  • Statistical Analysis Plans
  • Case Report Forms
  • Manuscripts
  • Risk Management Plans
  • Abstracts
  • Posters
  • Technical Reports
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