Surviving your PMTA just got a whole lot easier.
CONTACT US FOR A FREE CONSULTATION
Who We Are
NN Analytics, Inc. was established in 2015 to support the rapidly developing vaping industry with honest and effective consulting and scientific support to our customers’efforts in achieving national and international regulation.
We currently house the single largest aggregate team of diverse curricular and extracurricular professionals in regulatory & compliance, manufacturing, software, and reverse-engineering experts from the vaping industry.
REGULATORY SERVICES - PMTA
The FDA Final Rule 21CFR Part 1100, 1400 and 1430 mandates all e-liquid manufacturers to comply with good manufacturing practices. Nude Nicotine Analytics will establish Quality Management System (QMS) to conform to contemporary regulatory requirements. In addition, we are experienced developing and implementing streamlined, cost-efficient quality plans for new and exiting businesses.
e-Liquid companies will be required to create, modify, maintain, archive, retrieve or transmit data records mandated by the new FDA regulations and must comply with cGMP standards which apply to recordkeeping. Nude Nicotine Analytics assesses your documentation and records system to ensure compliance with cGMP requirement. We will also assist you in establishing and regularly update a documentation and record system.
The Nude Nicotine Analytics team is expert at auditing internal and external regulatory systems, processes and procedures. Whether you are preparing for an FDA Pre-Approval Inspection, have received an FDA Inspection Notice, or need to perform an FDA mock audit as part of your inspection readiness plan, we can assist you. Our team can provide you with a detailed, comprehensive gap analysis of your company and vendor regulatory requirements, to identify compliance related deficiencies.
Nude Nicotine Analytics provides employee training to small and large groups. All of our corporate trainers possess advanced degrees and have ample years of experience working in the FDA regulated industries. e-Liquid companies may customize their educational curriculum by choosing from our comprehensive selection of FDA and e-Liquid related content.
Direct interaction with the FDA is a stressful, sometimes intimidating experience, even when conducted under the best of circumstances. Nude Nicotine Analytics is available to alleviate your corporate anxiety by offering support during this challenging time. If you have received a warning letter from the FDA, we can prepare you for the audit by providing pre-inspection guidance.
We're Here To Help You
Why work with us?
We built a team of high quality analyists who receive internal training on industry lead standards.
We have a proven track record. Our experts will always complete the task asked of them.
We care about our clients and we are always available to answer your questions.
We can represent you - data in hand - for your FDA review.
Still have questions? Contact us and one of our experts will get back to you as soon as possible.