ComplyFDA services

 

Why is it important to stay on top of regulatory activity?

The life science industry is highly regulated, with laws and regulations which must be followed to ensure patient safety and product quality. Failure to comply with these regulations can result in serious consequences, including costly fines and remedial actions.

 By monitoring regulatory activity, organizations may identify trends and changes in the regulatory landscape and proactively address potential risks,

What does ComplyFDA offer that will help you monitor and stay on top of regulatory activity?

(Pharmaceutical, Medical Device, Biologics/Dietary Supplements, Combination Products) Cites Insider Intelligence is a focused report that provides citation level data detailing all regulatory activity during a rolling 24-month period. Our report is an excellent tool to stay informed about regulatory activity in the (pharmaceutical, Medical Device, Biologics/Dietary Supplements, Combination Products) industry.

We provide detailed information about the specific regulations violated in each citation and insightful trends facilitating regulatory risk evaluation and remediation.

There are several benefits to using (Pharmaceutical, Medical Device, Biologics/Dietary Supplements, Combination Products) Cites Insider Intelligence, including:

1. Comprehensive coverage

Our report covers all regulatory activity during a rolling 24 month period, refreshed quarterly,  providing a complete picture of the regulatory landscape. This includes all FDA as activity with detailed information about specific regulations violated.

1. Actionable insights

Our report provides detailed insights into regulatory activity, helping identify trends and changes in the regulatory landscape.  Current subscribers use this information for management review, audit preparation and prioritization of areas with significant risk, training, strategic plans and promoting a culture of quality and compliance.

1. Time-saving

Monitoring regulatory activity can be time-consuming, especially for organizations with limited resources. Our report saves you time by providing comprehensive data and insights in one place, to readily focus on  business critical tasks. Active links to all regulations and citations without navigating the FDA site provides quick access to information used for training, benchmarking and understanding how regulations are applied.

1. Customizable

 Reports may be customized to meet the unique needs of your organization.

Why choose ComplyFDA?

 Our philosophy is centered around balancing both quality/compliance and business requirements to provide solutions specific to the unique customer needs. Our team of experts have decades of experience in the life science industry and are dedicated to helping you achieve business success and quality/compliance success.

In addition to our (Pharmaceutical, Medical Device, Biologics/Dietary Supplements, Combination Products) Cites Insider Intelligence report, we offer a wide range of tools and resources to help you stay compliant, including:

1. Expert guidance

Our team of experienced regulatory professionals is here to help you navigate the complex world of FDA regulations providing a deep understanding of how the regulations apply and what risks your organization may have..

1. Training and education resources

We offer a range of training and education resources to help you and your team stay up-to-date on the latest FDA regulations. Customized training includes online courses and in-person training sessions to provide a solution best fitting your needs.

1. Compliance monitoring and reporting tools

Our compliance monitoring and reporting tools provide valuable data to evaluate risk, benchmark performance and develop training to create strong compliance awareness and quality culture.

What are warning letters and 483s?

An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice.letter.

Why is it important to avoid warning letters and 483s?

Receiving a warning letter or 483 can have significant consequences for an organization. Not only does it harm a company’s reputation, but it can also result in costly recalls, legal action, and  possible suspension of operations. In addition, companies that receive warning letters or 483s are often subject to increased regulatory scrutiny, which can be time-consuming and expensive.

How can ComplyFDA help?

At ComplyFDA, we understand the importance of staying compliant with FDA regulations. That’s why we offer a range of tools and resources to help you avoid warning letters and 483s, including:

1. Expert guidance from industry professionals

Our team of experienced regulatory professionals  are available to help you navigate the world of FDA regulations. We offer guidance  ranging from quality systems and documentation to product labeling and advertising.

1. Training and education resources

We offer a range of training and education resources to help you and your team stay up-to-date on the latest FDA regulations. Customized training includes online courses and in-person training sessions to provide a solution best fitting your needs. .

1. Compliance monitoring and reporting tools

Our compliance monitoring and reporting tools make it easy to track your compliance efforts and stay on top of any potential issues. Our compliance monitoring and reporting tools  provide valuable data to evaluate risk, benchmark performance and develop training to create strong compliance awareness and quality culture.

Why choose ComplyFDA?

ComplyFDA is a collaborative partner to your team. Our team of experts are dedicated to helping you navigate the world of FDA regulations  to achieve business and compliance success. With our comprehensive tools and resources, you can rest assured you are doing everything possible to avoid warning letters and 483s.

In addition to our commitment to compliance,  some additional considerations for choosing ComplyFDA:

• Our platform is easy to use and navigate, with a user-friendly interface that makes compliance simple and straightforward.
• We offer flexible pricing options to fit any budget, so you can choose the plan that works best for your company.
• Our team is available to provide support and guidance whenever you need it, ensuring that you always have the help you need to stay compliant.

Complying with FDA regulations is essential for success in the life science industry. With ComplyFDA, you can rest assured that you are doing everything possible to minimize compliance risk. Our comprehensive tools and resources, coupled with our expert guidance and support, your team can efficiently achieve both business and compliance success. Contact us today to learn more about how ComplyFDA can help

​WE ARE REGULATORY COMPLIANCE, GOVERNANCE ​​​​​​​​​​​​​& PROJECT MANAGEMENT SOLUTIONS SPECIALISTS

ComplyFDA provides lean alignment between business, engineering, quality, IT, tech services and manufacturing while maintaining overall governance and regulatory compliance.

Check out our regulatory insights and join our quarterly newsletter. Our newsletter is built to empower you as you reduces risk, benchmark performance, and build out process improvement, all while avoiding FDA warning letters, and FDA 483s