Ingredient Identity, a California-based regulatory management consulting firm to companies in the food and dietary supplement industries, has announced four new divisions that it says will enable more customers to achieve and maintain GMP compliance faster.
The company also plans to hire several specialised regulatory and quality assurance experts this year to meet the growing demand for outsourced FDA consulting support, new dietary ingredient (NDI) filings and GRAS notification services.
Ingredient Identity said that it has reinvested heavily over the last year in the development of a scalable platform for its customized GMP regulatory services and quality program solutions, which allows for rapid client implementation. The rollout of tailored offerings, inclusive of full documentation and company-specific standard operating procedures (SOP's) can now be completed in a matter of days to just a few weeks regardless of the complexity, size of operation or physical location(s), the company said.
From small, own-label distributors to the largest vertically-integrated companies in this industry, which must comply with FDA Good Manufacturing Practices, a turnkey set of protocols bolstered by Best Compliance Practices are claimed to help greatly reduce overall regulatory and legal risks from operating out of compliance or selling misbranded and/or adulterated products. The core management platform supports large multi-variable projects such as GMP compliance audits, due-diligence assessments, NDI filings and GRAS notifications that can have numerous tasks and teams working simultaneously across departments to meet aggressive deadlines.
"We are highly conscious of not disrupting our clients daily operations by burying them in excessive procedures, which is why our Quality Program Optimization service is crucial to saving mid-to-large cap companies hundreds of thousands of dollars and in some cases millions each year," said Brandon Griffin, CEO of Ingredient Identity. "While a client may already be GMP compliant, often we walk in and find inefficiencies that are very costly from a production revenue perspective so it doesn't hurt to have our experts spot check operations. Looking inward, we have been on a solid annual growth trend of nearly 700% in gross revenue, so our approach is working and we are continually developing specialized teams, but there is more room to improve. Furthermore, we only bill for work we do, which helps us keep to clients' budgets and we don't operate using a 'monthly retainer' billing practice like most of our competitors – such a practice only really benefits the consultant(s) when you start looking into it."
Ingredient Identity has established four specialized divisions to support clients with their specific project and compliance needs.
The Regulatory Guidance Services (RGS) group conducts high-level regulatory consulting, strategic planning and quality program guidance for customers that require extensive industry expertise and proven systems to effectively plan, scale operations or address matters of high legal and/or regulatory risk.
The Quality Development Services (QDS) team heads the evaluation, development and implementation of Best Compliance Practices, facility GMP auditing or vendor qualifications and general technical support for customers with ongoing regulatory needs.
Labeling Review Services (LRS) handles the development and review of content for labels, packaging, claims substantiation, website reviews and advertising scripts to ensure compliance with US or other international regulatory bodies.
Lastly, Brand Reputation Services (BRS) is described as a highly specialised team that is designed to guide customers through crisis management and post-event recovery planning that are facing class action lawsuits, FTC actions, FDA Warning Letters or Consent Decrees and even criminal charges; programs are designed to guarantee results and mitigate major matters negatively impacting overall brand reputation and value.
