Pharmaceutical Regulatory Consulting Key Terms

Learn the key terms associated with pharmaceutical regulatory consulting

Pharmaceutical regulatory consultants ensure that regulations and standards of quality are met in medical device and medication dispensing. They also monitor and regulate drug trials and trial data report submissions. Pharmaceutical consultants enforce regulations of quality, sanitation, and proper procedure in all areas of pharmaceutical trials, research and practice.

It's important to understand key terms associated with pharmaceutical regulatory consulting to ascertain if working with a pharmaceutical regulatory consultant will benefit your business, or if a job in the consultancy field is right for you.

 

New Drug Submissions

A New Drug Submission, or NDS, is an application that must be filed with the FDA when a generic form of a drug is introduced to the pharmaceutical market. The NDS must prove that the generic drug form is as potent and effective as the brand name equivalent.
Try: Science Careers Magazine explains the process of filing an NDS claim and the role that pharmaceutical regulatory consultants play in the filing.

FDA Review Division

The FDA Review Division is a division of the FDA that reviews and inspects new drugs before they are released onto the market to ensure their effectiveness and safety, and to identify any potential side effects. Pharmaceutical regulatory consultants often work with FDA agents in this process.
Try: The FDA explains the process for drug review and new drug investigation, and how the process is key in pharmaceutical regulation.

Regulatory Affairs Professional Society

The Regulatory Affairs Professional Society (RAPS) is a professional organization of pharmaceutical regulatory consultants and service providers. RAPS provides educational and support resources as well as news and drug trial regulation information for members.
Try: RAPS explains the educational and professional resources it provides to pharmaceutical regulatory consultant members.

Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) refers to a regulatory guideline implemented by the US Food and Drug Administration in the laboratory testing and manufacturing of pharmaceuticals. Pharmaceutical regulatory consultants are familiar with GMP and can provide assistance with achieving compliance.
Try: GMP 1st explains GMP and how this federal guideline helps to ensure quality in pharmaceutical services and manufacturing.

Medical device services

Medical device services is the testing of medical and laboratory devices used in drug and clinic trials to ensure the devices are in proper working order and sanitized properly. Regulatory consultants often offer this service.
Try: Intertek explains medical device services that their international company offers to pharmaceutical businesses and how these services ensure quality laboratory testing and device operation.

Medical Dictionary for Regulatory Activities (MedDRA)

Medical Dictionary for Regulatory Activities (MedDRA) is a continuously updated and internationally recognized terminology list focusing on regulatory practice in the medical and pharmaceutical industries.
Try: MedDRA's website explains its function and how it benefits regulatory consultants, physicians and other medical professionals.

Copyright © 2011 Business.com, Inc. All Rights Reserved.

---