Compliance Consulting - We have a proven strategy for FDA compliance, which we will help you execute, that identifies compliance gaps and develops a risk-based corrective action plan, ensuring you will pass FDA inspection.Learn More
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
You are invited to join us for a webinar. Please click here to learn more.
Blog & Updates
July 23, 2015
The differences in good clinical practice, good laboratory practice, and good manufacturing practice audits Audits are a mainstay in the pharmaceutical industry. Virtually every pharmaceutical company is subject to them at one time or another. However, different audits exist depending on the regulations being evaluated. Some audits are designed to address Good Clinical Practices, whereas […]Continue Reading
July 10, 2015
Regulatory compliance training is important for personnel in a pharmaceutical company to remain current with appropriate regulations. In preparation for announced and unannounced inspections by the Food and Drug Administration or other regulatory agencies, personnel need familiarity with the latest national and international guidelines. As such, pharmaceutical and medical device executives should understand what features […]Continue Reading
June 4, 2015
Virtually every device manufacturer that conducts studies on humans needs to determine whether an investigational device exemption is necessary. As such, device manufacturers should understand what an investigational device exemption is, to which devices it applies, and how to obtain an investigational device exemption if it is needed. What is an Investigational Device Exemption? An […]Continue Reading
May 15, 2015
An overall goal of pharmaceutical executives is to ensure that the products developed by their companies are approved by the appropriate agencies and marketed appropriately. However, this can pose a challenge given the changing guidelines of agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency. At best, not following these […]Continue Reading
May 8, 2015
While the Medical Device Single Audit Program (MDSAP) is still being piloted, it is crucial for medical device manufacturers to understand the potential benefits and implications of an international single audit program. There are many advantages to a MDSAP for both the medical device manufacturer and regulatory authorities. Developed by the International Medical Device Regulators […]Continue Reading
The owner of TheFDAGroup.com will not be liable for any errors or omissions in this information nor for the availability of this information. The owner will not be liable for any losses, injuries, or damages from the display or use of this information.