How Can FDA Compliance Consultants Benefit Your Next Product Launch?
Before an OTC Drug or even a cosmetic/personal care product can be brought to market in the US, it must first undergo conceptualization, development and a rigorous testing process to ensure that it meets FDA requirements for safety (cosmetic/personal care products) and complies with the applicable OTC Drug Monograph. If you’re looking to launch a new product from either of these categories, there are crucial steps that must be taken in order to ensure the quality, safety and efficacy of the product and its compliance with FDA standards.
When it comes to strategizing FDA/GMP compliance, you shouldn’t do it alone. FDA compliance consultants can be your greatest asset in executing an efficient product launch in the shortest time possible. The following are 4 examples of how FDA compliance consultants can benefit your next product launch.
Take the complication out of compliance.
FDA regulations can be difficult to understand and they are not written with the intent to capture every possible compliance scenario. As a result, many of FDA’s current compliance expectations are not clearly defined in ‘black-and-white’ but actually fall within a ‘grey’ area which requires a compliance expert to fully understand. FDA compliance consultants bring a wealth of knowledge and invaluable experience dealing directly with FDA to you when planning product launches and conducting everyday manufacturing activities. In short, they take the complication out of compliance.
Guide you through any challenge which may arise.
If you’ve launched a product before, you know that challenges can arise at the least opportune moment. This is inevitable, even when a good launch plan has been devised. Stability testing failures, validations which do not yield expected results, vendor issues and regulation changes are just a few examples of the challenges which may arise along your pathway to product launch. Having an FDA compliance consultant at your side will enable you to recover faster from these unexpected pitfalls, getting your launch back on track as quickly as possible.
Availability when you need them most.
Working with an FDA compliance consultant on your next product launch allows you to have their expertise at your fingertips, whenever you may need it. Whether you utilize their services for specific planning or problem-solving needs or to assist throughout the entire process, your FDA compliance consultant will be fully committed to helping you achieve your product launch goals.
Compressed launch cycle through efficient planning and rapid response to unexpected issues.
Knowing all of the applicable compliance requirements up front allows for the most efficient planning of your product launch. Having a seasoned compliance expert at your side when unexpected issues arise allows you to minimize downtime as you react to and correct these issues. Taken together, these benefits derived from utilizing the services of an FDA compliance consultant will allow you to bring your product to market in the shortest time possible.
Good FDA compliance consultants are driven by integrity. They will assist you in assuring that your product is safe, meets all applicable quality and regulatory standards, and is launched in the most expeditious manner Their wealth of experience dealing directly with FDA enables them to provide you with time-saving advice, and the most cost-effective solutions to your compliance issues.
At CPT℠ Labs, our consulting division is comprised of well-seasoned and compliance-savvy consultants who can provide assistance in all of the following areas:
- Remediation of FDA Compliance Issues
- Auditing Services
- Quality Management System Improvement
- On-Site Training
- Supply Chain Quality Management
- Validation Design
- OTC Drug Launch Planning
- Review of Product Claims for the US Market
- Determination of Legal Status of Proposed Products for the US Market
- Other Consulting Services, upon request
