Companies with varied self-care industry expertise*
ADM Health & Wellness – A leading manufacturer and marketer of naturally derived bioactive components, from agricultural crop, that promote health, supplying the food, drug and cosmetics industries with nutraceutical ingredients.
Areas of Focus: Contract Packaging - Flexible Packaging; Ingredient Supplier; Supply Chain Operations/Logistics Services
Advantage Solutions – A sales, marketing and supply chain company focused on OTC healthcare brands. Advantage combines the know-how of major OTC companies with the capabilities of best-in-class third-party sales and marketing agencies, resulting in the most comprehensive, effective and efficient solutions for OTC healthcare brands - from strategic planning, sales execution to supply chain. OTC Healthcare - it's all we do!
Areas of Focus: Consulting - Market Data & Consumer Insights; Consulting - Marketing; Consulting - Retail Strategy; Consulting - Sales; Consulting - Strategy; Distribution Services; Information Technology Services; Supply Chain Operations/Logistics Services
GMPACT – Ms. Jennifer Ahearn specializes in FDA regulated product compliance. GMPACT has assisted pharmaceutical, medical device and dietary supplement companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms, OTC products, medical devices, combination products and dietary supplements. The GMPACT goal is to provide manufacturing quality teams support for regulatory issues so that our clients can maintain good manufacturing practices (GMP) while gaining efficiency in manufacturing. GMPACT offers assistance through FDA compliance audits or through larger scope FDA 483 remediation activities. The GMPACT team has assisted manufacturers by providing audits, data review, writing and reviewing investigations, mentoring on investigations, performing root cause analysis, gap assessments, and developing quality systems from the ground up.
Areas of Focus: Consulting - Regulatory & Scientific
TLC Regulatory and Laboratory Consulting – TLC Regulatory and Laboratory Consulting (TLC) provides (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 management 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. TLC also works with clients on regulatory remediation efforts and necessary corrective and preventative actions. 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.
Areas of Focus: Consulting - Regulatory & Scientific; Consulting - Strategy; Contract Manufacturing; Dietary Supplements; Other Products (Beauty, Rx, etc.); Over-the-Counter Medications; Manufacturer - Private Label
Touchpoint Regulatory Affairs Consulting, LLC – Touchpoint Regulatory Affairs Consulting offers Regulatory Affairs consulting specializing in the unique needs and challenges of the self-care industry. We bring a strategic lens to all our client interactions, whether it is new product development, Rx to OTC switch, OTC Monograph, labeling and claims, or regulatory intelligence and research. We also offer strategic support for the assessment and transformation of regulatory processes as well as training and coaching of new regulatory hires. Touchpoint is led by Lauren Quinn, Principal, an experienced executive who has been navigating the ever-changing world of Consumer Healthcare regulations for over 20 years, successfully leading global regulatory teams for major companies like Wyeth, Pfizer, Novartis, GSK and Haleon.
Areas of Focus: Consulting - Regulatory & Scientific
*Not all companies from any given area of focus may be listed; The Associate Reel will highlight different CHPA Associate Member companies and their area(s) of focus on a random, rotating basis.