Overview of the Regulatory Process

Corporate Compliance

ELiquidGMP provides e-liquid manufacturers with a comprehensive plan, to ensure adherence to the regulatory requirements of the Family Smoking Prevention and Tobacco Control Act (2009) and 21 CFR 1100.

Regulatory Submission

ELiquidGMP provides eliquid manufacturers with a regulatory strategy focused on introducing new eliquid products to market. We author premarket review applications, substantial equivalence and modified product submissions, after conducting an extensive review and compilation of submission based data. In addition, we can assist with company registration, product listing, post-market reporting, labeling, advertising and promotion.

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. ELiquidGMP will establish Quality Management System (QMS) to conform to contemporary regulatory requirements. In addition, we are experienced with 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. ELiquidGMP assesses your documentation and records system to ensure compliance with cGMP requirement. We will also assist you to establish a documentation and record system and audit and/or update them periodically.

Auditing

The ELiquidGMP team are experts 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. We can provide 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, and can be 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

ELiquidGMP 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 industry. Eliquid companies can customize their educational curriculum, by choosing from our comprehensive selection of FDA and eliquid related content.

FDA Interaction and Remediation

Direct interaction with the FDA is a stressful, apprehensive experience, even when conducted under the best of circumstances. ELiquidGMP 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 the parties. ELiquidGMP offers comprehensive remediation services for organizations who receive a Warning Letter, after FDA inspection. We can structure and implement an effective remediation plan to efficiently 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, which result from a signed Consent Decree or Corporate Integrity Agreement.