Regulatory complexity within the OTC drug, cosmetic, and dietary supplement space is intensifying. Here’s how CPT℠ Labs’ consulting services help manufacturers and brands get ahead of it.
1. FDA compliance remediation that addresses the “root cause”, not just the citation point.
When a FDA 483 observation or Warning Letter arrives, the response strategy matters as much as the correction itself. CPT℠ Labs consultants work through FDA compliance issues at the level of root cause analysis, corrective action formulation, and response letter generation. The goal is a defensible, durable fix; not just a reply that closes one issue while leaving underlying vulnerabilities intact.
2. GMP audits that prepare you for regulatory inspection, not just an internal exercise.
CPT℠ Labs offers third-party GMP compliance audits across CMOs, suppliers, testing laboratories, and warehouse and logistics operations. The audit scope includes FDA inspection preparedness, quality audits of cosmetic and personal care facilities, and third-party internal audits. For quality and compliance teams managing extended supply chains, third-party audit documentation provides both operational visibility and an independent evidentiary record of due diligence.
3. QMS improvement grounded in gap analysis, not generic frameworks.
A Quality Management System assessment by CPT℠ Labs begins with a current-state GAP analysis versus applicable standards. From there, consultants support the development of cost-effective improvement strategies, site-specific SOPs, and Quality testing programs — including “skip-lot” and “reduced” testing protocols for manufacturers attempting to manage high-volume production. The approach is calibrated to the organization’s actual risk profile and operational structure, not a standardized template.
4. MoCRA preparedness that goes beyond checklist compliance.
The Modernization of Cosmetics Regulation Act introduced new requirements, including adverse event reporting, facility registration, product listing, and product safety dossiers, which represent a structural change in how cosmetics are regulated in the U.S. CPT℠ Labs consulting support covers MoCRA requirement delineation, adverse event program development, product safety dossier creation, and compliance strategy. For brands and manufacturers still mapping their MoCRA obligations, early engagement with an experienced consulting team significantly reduces the risk of downstream remediation.
5. Supply Chain Quality Management that extends oversight to vendors and service-providers.
Substandard quality of purchased materials and services are among the most common sources of product-quality breakdown. CPT℠ Labs’ supply chain consulting covers vendor qualification programs, COA validation, Quality Agreements, and quality monitoring, including “skip-lot” and “reduced” testing program design. For procurement and Quality teams attempting to manage complex sourcing scenarios, this level of supply chain oversight supports both product integrity and regulatory defensibility.
6. Training programs that build internal competency, not just awareness.
CPT℠ Labs offers either on-site or virtual training in GMP, GLP, GCP, and MoCRA across focused topic areas including but not limited to Data Integrity, change control, OOS investigations, adverse events, and stability. Training programs are designed to build internal operational knowledge that makes compliance sustainable, particularly for organizations looking to strengthen their QMS or onboarding new regulatory requirements for the first time.
Trust CPT℠ for Your Regulatory and QA Consulting
Contact our Consulting department today to learn more and get started!