REGULATORY SERVICES - PMTA
REGULATORY SERVICES - PMTA
What we do
At N.N. Analytics, regulatory services begin with our regulatory consultants, many of whom are former senior regulators themselves. Our consultants have considerable experience preparing regulatory strategies, as well as managing pre-submission meetings with the FDA and other regulatory bodies worldwide.
Let us help you prepare Pre-market Tobacco Application (PMTA), drawing upon all the global resources at N.N. Analytics including Toxicology Risk Assessment, process validation, product stability studies, emission tests, and labeling/package compliance.
N.N. Analytics provides e-Liquid manufacturers with a regulatory strategy focused on introducing new e-Liquid products to the market. After conducting an extensive review and compilation of submission based data, we author premarket review applications, substantial equivalence, and modified product submissions. In addition, we can assist you with company registration, product listing, post-market reporting, labeling, advertising, and promotion.
If you’re not sure where to start with testing or need help improving your processes to ensure better testing, we can help. We can represent you – data in hand – for your FDA review.
cGMP (current Good Manufacturing Practices
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.
Documents, Records Control, and Retention
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.
Auditing
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. Upon discovery,regulatory gaps will be analyzed, from a risk management perspective, then addressed through the implementation of a corrective and preventive action plan. Our auditing services span the entire e-Liquid products development and management lifecycle, from research and development, through post-marketing surveillance and promotion. In addition, we frequently audit 3rd party suppliers and vendors, such as contract research organizations, contract manufacturing organizations and contract packaging organizations.
Training
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.
FDA Interaction and Remediation
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. In addition, we are available to accompany you during the inspection to help mediate any points of contention between parties. Nude Nicotine Analytics offers comprehensive remediation services for organizations who receive a Warning Letter, after FDA inspection. We can structure and implement an effective remediation plan to address any compliance deficiencies or violations. If your company has received a Warning Letter, we can author a satisfactory Company Response and devise a corrective action plan in adherence to the 15-day response timeline. In addition, our consultants are available to assist larger corporations with corporate compliance or regulatory remediation projects resulting from a signed Consent Decree or Corporate Integrity Agreement.