TLC Regulatory and Laboratory Consulting Services

About TLC

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 assisting clients throughout the world with the development, improvement and implementation of quality systems that are scientifically sound, efficient, practical, and compliant with all applicable FDA regulations. TLC performs mock FDA inspections, gap analyses, due diligence assessments, 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. In addition, TLC conducts thorough and detailed quality incident investigations including out of specification (OOS) investigations, non-conformances, material reviews, deviations, general quality investigations, and consumer complaint investigations and needed escalations. 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 including seminars, webinars and on-site presentations on topics of cGMP requirements, quality systems, and laboratory operations. All TLC services are intended for the purposes of Elevating Quality, Thoughtfully.

TLC Specialties

Quality Management Systems

Current Good Manufacturing Practice (cGMP) Compliance

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).

Current Good Manufacturing Practice (cGMP) Compliance

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.

FDA Mock Inspection – Surprise inspection of a facility to assess readiness to successfully receive an FDA inspection.
Due Diligence Assessment – Assessment of a physical facility, personnel, QMS, and/or regulatory compliance on behalf of third-party for potential purchase.
Gap Analysis – Analysis of current facility and QMS for regulatory compliance with expert that provides immediate feedback and discussion throughout.
Audit – Audit of current facility and QMS for regulatory compliance.

Regulatory Remediation

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:

Remote Regulatory Assessments (RRAs);
Remote Interactive Evaluations (RIEs);
Form 483 - List of Observations from on-site inspections;
Warning Letters; and
Consent Decrees.

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.

Investigations

Regulatory Remediation

In addition, TLC assists with the conduct of thorough and detailed quality incident investigations including:

Out of Specification (OOS) investigations;
Non-Conformances;
Material Reviews;
Deviations;
general Quality Investigations; and
Consumer Complaint Investigations that may require reporting to the FDA if it is a Serious Adverse Event or Experience (SAE).

Laboratory OPerations

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:

Sample Management
Chemical and Standards Management
Equipment Qualification, Calibration, and Use
Test Method Validation, Verification, and Use
Out of Specification (OOS) Investigations
Stability Programs

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Training

Laboratory OPerations

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:

Seminars;
Webinars; and
On-Site Presentations

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TLC Regulatory and Laboratory Consulting Services

TLC Specialties

Quality Management Systems

Current Good Manufacturing Practice (cGMP) Compliance

Current Good Manufacturing Practice (cGMP) Compliance

Current Good Manufacturing Practice (cGMP) Compliance

Current Good Manufacturing Practice (cGMP) Compliance

Current Good Manufacturing Practice (cGMP) Compliance

Regulatory Remediation

Regulatory Remediation

Regulatory Remediation

Investigations

Regulatory Remediation

Regulatory Remediation

Laboratory OPerations

Laboratory OPerations

Laboratory OPerations

Training

Laboratory OPerations

Laboratory OPerations

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