- 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 Assurance 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 assurance 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
Our Mission:Actively engage in the process to improve health and wellness by aligning with clients objectives to bring quality products to the consumer
Our approach:Industry Professionals and former FDA Inspectors will serve as an asset to the client and effectively and efficiently mitigate and resolve FDA issues in a practical, straight-forward approach
- Develop, maintain or re-establish the client's credibility with the FDA.
- 100% Client satisfaction.
What makes Compliance Insight special?
- We offer hands-on, effective, value-added FDA compliance solutions
- We focus on skillful, comprehensive, and results-oriented actions
- Our services are practical, straight-forward, and diligently implemented
- We are good stewards of your money
What we offer:
- Decisive oversight to ensure that FDA compliance issues are strategically resolved.
- Diligence to assure the client is completely satisfied - we calve integrity.
- We are compassionate about what we do - FDA Compliance and ClientSuccess.
- Our skilled colleagues are committed to the client objectives - no changing the team.
- Client success is our main goal - the client will see effective, systemic results.
Trustworthiness, Respect, Responsibility, Fairness, Empathy, and Ownership
Compliance Insight serves the following industries:
- Clinical Trial Investigator
- Compounding Pharmacy
- Legal Firms
- Medical Device