Regulatory Affairs

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Regulatory Affairs

There are major differences in the way clinical trials are organized and designed for drugs and medical devices. Regarding the regulatory conduct of the studies, the differences are in the details. Nor Consult experts implement meticulous strategies to address those aspects when submitting your drug or medical device clinical trial for approval. Our policy is to always be our client’s reliable guide and partner in compliance.

Submissions

Procedures for regulatory submission and approval of a clinical research require more»

Legal Representation

Our company’s specialists are ready to be the client’s liaison with regulatory authorities more»

Regulatory Medical Writing

In such highly regulated field as clinical research it is crucial to understand the importance more»

REGULATORY Submissions

Procedures for regulatory submission and approval of a clinical research and medical products require different strategies for drugs and for each type of medical device. Extensive knowledge of all of those aspects is essential. At Nor Consult, LLC, we have highly skilled personnel and resources to guide the client through all steps of the submission process, both at the time of application for the study approval and at the time of application for the drug or device approval for marketing. Nor Consult regulatory services include lifecycle maintenance of clinical studies authorizations in compliance with local requirements:

  • FDA, Health Canada and European national competent authorities and other country-level review boards
  • Ethical committee and site-specific IRB submissions
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Legal Representation

Our company’s specialists are ready to be the client’s liaison in legal cases.  Whether you are a device or drug manufacturer facing a liability suit or you are an attorney representing the patients in medical damages claims, we will provide expert witness and evidence background to promote your case.  Ask us about our successful history of prior representations.

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Regulatory Medical Writing

In such highly regulated field as clinical research it is crucial to understand the importance of flawless documentation. Documents involved in each stage of the trial must be prepared on the highest level of accuracy, in a timely manner, and what’s critical, strictly follow the federal guidelines and IRBs’ requirements.

Nor Consult will prepare:

  • Clinical Study Protocol
  • Informed Consent Form
  • Investigator Brochure
  • Investigator Newsletter
  • Literature Summary
  • Clinical Study Report
  • Statistical Analysis Plan
  • Case Report Form
  • Manuscript
  • Risk Management Plan, etc.
  • .
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