TLC Regulatory and Laboratory Consulting (TLC) provides Food and Drug Administration (FDA) regulatory consulting services and scientific expertise to the dietary supplement, pharmaceutical, tobacco, and cannabis industries. This includes the development and implementation of a quality management system (QMS) that is compliant with the FDA requirements for Current Good Manufacturing Practices (cGMPs), and is scientifically sound yet, practical to ensure that the QMS controlled processes and procedures will consistently result in products that are manufactured to meet pre-established quality specifications. TLC also works with clients on regulatory remediation efforts, investigations, and necessary corrective and preventative actions (CAPAs). In addition, TLC has extensive experience with the development, improvement, and implementation of a laboratory facility and its’ QMS to ensure compliance to Good Laboratory Practices (GLPs), as well as cGMPs which are vital to the FDA regulated industry. Training is an essential part of cGMP compliance and building a smart QMS. TLC strongly believes in continuous education, and proudly provides a variety of training services. All TLC services are intended for the purposes of Elevating Quality, Thoughtfully.
A quality management system (QMS) is the formal, documented system that dictates all controlled processes and procedures to obtain and consistently maintain product quality and regulatory compliance. TLC assists clients throughout the World with the development, improvement, and implementation of a QMS that is scientifically sound, efficient, practical, and compliant with all applicable FDA regulations, particularly Current Good Manufacturing Practices (cGMPs).
To assess the state of compliance to Current Good Manufacturing Practices (cGMPs) and other required regulations, TLC performs mock FDA inspections, due diligence assessments, gap analyses, and audits directly for clients as well as audits of contracting partners including manufacturers, packagers, distribution warehouses, and laboratories.
TLC also works with clients on regulatory remediation efforts and necessary corrective and preventative actions (CAPAs). This CAPA remediation can be internally driven, from a previous assessment, or a required external effort dictated by the FDA for:
Other communications such as necessary responses to Deficiency Letters from FDA submission scientific reviews and Pre-Approval Inspections (PAIs) can be drafted and reviewed by TLC for clients.
Participation and support during an FDA inspection or meeting is another TLC consulting service.
In addition, TLC assists with the conduct of thorough and detailed quality incident investigations including:
TLC has extensive experience with the development, improvement, and implementation of a laboratory facility and its’ quality management system (QMS) that is compliant with overall Good Laboratory Practices (GLPs) and Current Good Management Practices (cGMPs), with the latter vital to the FDA regulated industry. A few of these QMS parts are:
Training services on topics of Current Good Manufacturing Practice (cGMP) requirements, quality management systems, laboratory operations; and other related issues can be conducted in various formats including: