- FDA 483 & Warning Letters
- FDA Inspection
- FDA 483
- FDA 483 Observations
- Top 10 Reasons For FDA 483
- FDA 483 Response
- Preventing Future 483 Problems
- FDA Compliance
- FDA Consent Decree
- FDA Training
- FDA Regulatory Filings
- Our Services
- About Us
FDA 483 & Warning Letters
Receiving a FDA 483 / Warning letters can be a high stress, frustrating experience. It is important to get in front of any FDA compliance issues so your company is driving the process.
We have the knowledge and resources to help your company navigate any FDA compliance issues.Learn More
FDA GCP & GMP Training
A good training system (GCP or GMP) is not only required by the FDA, but they make sound business sense. Use our website to learn how to comply with FDA training requirements and how to implement an effective training program. Compliance Insight also provides extensive training support to keep your training process in compliance.Learn More
Quality Control is a critical function for your company. Many organizations don’t have the depth of talent or the time to implement their own quality control organization.
Learn how you can implement a virtual QA team that is both cost effective and keeps your quality control function on track.Learn More
FDA Regulatory Filings
The FDA has different regulatory filing requirements your company needs to follow. Our site has information on ANDA, 505(b)(2), IND, CMC and DMF filing requirements.
Compliance Insight can help you complete all your FDA Regulatory Filings, contact us today to discuss your Regulatory Filing needs.Learn More
Working With Compliance Insight
At Compliance Insight, it is our belief that a pro-active solution works best. This sets the stage for long-term success. Our thorough evaluation identifies your regulatory and compliance issues.
We draw from our years of experience to offer you customized solutions that are realistic and effective.
Compliance Insight serves the following industries:
- Clinical trial investigator
- Medical device
- Food industries
These highly regulated industries are required to maintain compliance with FDA regulations in order to market their products in the US.
Support industries such as contract testing labs, raw material and component suppliers, and contract manufacturers are also subject to these regulations.Click Here to View Our Services