A prominent global $500M+ Direct Response company looked to outsource part of its regulatory oversight for its non-preferred vendors based on recent changes in upper management. The company also needed to better understand its overall regulatory and legal risks based on the existing product portfolio and compliance system, in addition to leveraging regulatory expertise for the development and sales of new products in targeted international markets.

Objectives:

• Evaluate entire current product portfolio and formulations, labeling and substantiation
• Establish a system within quality operations to quickly flag medium and high compliance risks
• Conduct all vendor qualification(s) for compliance with GMPs and foreign markets regs
•  Develop new system to monitor Quality and Regulatory Performance Metrics of new Direct Response strategies

Results:

• Completed the full portfolio evaluation of over 100 products in 8 weeks
• Implemented new procedures allowing for prompt escalation of critical compliance issues
• Provide ongoing vendor qualifications and auditing, both domestic and international based on new product initiatives

A small virtual company with an exciting new product needed to establish their quality program from scratch in order to operate seamlessly and in compliance with all outside vendors. Their knowledge of the product and ingredients was solid, but the in-house experience in quality control and regulatory was insufficient to get the product quickly to market and operate in GMP compliance.

Objectives:

• Master technical specifications for the product
• Set internal/external specifications for routine QC analysis including methodology
• Establish marketing claims for customer presentation and market penetration
• Complete training of QA/QC personnel and define needs for GMP Compliance Success

Results:

• SOP’s and compliance documents generated and implemented in under six weeks
• Established ongoing analytical evaluation criteria
• Successfully launched product both domestically and internationally

Based on the research of a renowned scientist, a company had co-developed a novel ingredient that constituted a New Dietary Ingredient (NDI). The challenges faced were in the evaluation of the technical aspects of the material based on its source and in the development of a strategy to get the ingredient to market given a changing regulatory environment.

Objectives:

• Complete regulatory evaluation of the material and its place in the regulatory realm
• Create total package of technical documentation for use in-house
• Complete technical specifications for the product used in analysis

Results:

• Completed technical specifications for the product in support of marketing efforts
• Successfully filed the NDI in 5 weeks to the FDA – no objection received

A company wanted to import, market and sell finished form Sports Nutrition and Bodybuilding dietary supplements into the US. The formulas were developed and sold internationally, but not in the US. The client needed to qualify their Supply Chain and establish Quality procedures that were not cost prohibitive, but still compliant, including determination of product claims and labeling.

Objectives:

• Complete regulatory evaluation of each product formulation, ingredients and labeling
• Establish standards of testing criteria for all formulations

Results:

• Comprehensive compliant label copy developed for all products intended for sale in the US region
• Determined and presented of essential documentation to allow successful importation
• Successfully launched products in the US market faster than anticipated
• Established new Product Complaint System inclusive of AERs and SAERs support protocols

A US private labeler received a 2nd Warning Letter after an initial Warning Letter was received following a surprise FDA inspection. The QA staff was inexperienced in both handling onsite FDA inspections and resolving a number of persisting quality issues to mitigate future non-compliance reoccurrences. Facing further regulatory and legal actions, the company sought outside expertise to lead company through the reorganization and training of new quality/regulatory personnel.

Objectives:

• Assess current situation and develop an achievable CAPA plan with representation to FDA
• Outline changes to operations in order to address future compliance matters
• Consult on budgetary planning requirements for future operations under new structure
• Guide marketing efforts in addressing brand damage and overall impact of the FDA actions

Results:

• Successfully represented client to FDA in order to close out all objections within 7 months
• Implemented new organizational strategy and training for Regulatory and Quality staff
• Created new technical marketing content and provided ongoing monitoring of social media sites

A large foreign based manufacturer of specialty raw materials was placed on import alert after FDA tests confirmed pesticide adulteration across various lots. The company took initiative to address the matter initially without outside regulatory guidance and lacked in-house expertise in addressing such matters, resulting in further FDA actions due to several inadequate responses and other insufficient corrective actions. After just three months the company lost their top two U.S. customers resulting in a loss of $3.8M in sales.

Objectives:

• Investigate all applicable SOP’s, supporting documentation, analytical methodology and associated raw data in month one
• Implement and document appropriate CAPA’s and issue adequate response to the Agency
• Institute new analytical screening regimen for all incoming whole or processed raw materials
• Identify, qualify and manage 3rd-party contract labs to support new testing regimen – document findings
• Present plan, import/export documentation and resulting data to Agency; maintain Agency contact until resolved

Results:

• Drafted and implemented new quality program (with a budget) to mitigate any future repeat
• Qualified three contract laboratories in first two months, inclusive of approving all study protocols
• Operational Gap Analysis identified several other non-compliance matters previously unknown/unaddressed
• Acted as primary point of contact to represent company to the Agency and provided sufficient updates and petitions
• Achieved GREEN LIST status within 10 months (NOTE: five consecutive imports were not sufficient)
• Advised on subsequent marketing strategy/efforts to rebuild trust of U.S. customers based on new practices and committments