IOur pharmaceutical scientists and regulatory experts work with you at every stage of development, providing consistently high quality and flexible services that enable you to achieve a marketplace advantage. Over...
Quality Auditing, Training & Consulting.
Unique solutions from exceptional experience
Experienced Consultants
Agency-level experienced consultants offer unique solutions and expert advice to help ensure your success.
Global Services
From on-site inspections to submission strategies and numerous services in between, our experts offer effective solutions for the healthcare and pharmaceutical industries.
Industry Insights
Check our latest blog post for a glimpse behind the scenes or a deep dive into a variety of industry-related topics.
Why You Can
Trust CK Pharmaceutical Consulting Solutions,
Our Values
After nearly 20 years in the pharmaceutical industry and clinical field, former FDA investigator and Consumer Safety Officer Charisse K. Green is well acquainted with the exacting specifications and numerous requirements presented to companies seeking to enter the business. Through CK Pharmaceutical Consulting Solutions, Green is offering her vast and detailed knowledge on a consulting basis to a select group of companies.
CK Pharmaceutical Consulting Solutions affords your company the opportunity to have a consultant on your team that understands first-hand what the regulators are looking for, one who has worked with numerous foreign regulatory bodies; including MHRA, Swiss Medic, and Health Canada to perform joint inspections including collaboration of inspection reports; and has personally evaluated, assessed and reviewed numerous Quality Management Systems for all FDA commodities. Having held the highest level of FDA certification in cGMP expertise, Green specializes in Biotech and Sterile Aseptic Manufacturing, APIs, pre-approval and GMP inspections.
CK Pharmaceutical Consulting Solutions makes the unparalleled experience of Green’s 15-year FDA career available for the pharma industry. Her multi-faceted agency background uniquely positions her to be able to deliver innovative solutions and extraordinary results for clients globally.
15 Years of FDA Consumer Safety Officer/Inspector/Auditor Experience
CK Pharmaceutical Consulting Solutions takes pride in delivering innovative solutions and extraordinary results for clients around the globe. Our unparalleled experience will help you achieve success.
Inspections performed in 20 countries
Over 100 inspections performed
+
Years pharmaceutical & clinical experience
Trusting Clients
Our Practice Areas
cGMP certified
Having received the FDA’s highest certification; we are able to provide guidance on systems to assure proper design, monitoring and control of manufacturing processes and facilities
Hands-on Inspection expertise
Specializing in complex inspections including biotech and sterilized manufacturing facilities as FDA Northeast Regional Drug Specialist.
International experience
Worked first-hand with numerous foreign regulatory bodies including MHRA, Swiss Medic, and Health Canada to perform joint inspections including collaboration of inspection reports.
Industry-wide legal and regulatory knowledge
Developed compliance programs involving API facilities, biotechnical companies, sterile drug manufacturers, blood banks, tissue facilities, clinical research facilities and contract testing laboratories.
Innovative systems
Performed international drug inspections as an inaugural member of the Dedicated Foreign Drug Cadre.
Strategic leadership
Demonstrated ability as a strategic leader and consensus builder in improving established quality systems and potentially developing new quality systems.
Satisfied Clients
Our small business had discovered what we felt to be a gap in the consumer grocery market and we started making plans to create the perfect product to fill it. As we were doing research, a partner suggested we reach out to CK Pharmaceutical Consulting Solutions to see if they could give us feedback from an FDA point-of-view. Charisse Green was amazing! She met with us, listened as we explained our idea, and in a very short time she got back to us with news that our proposed product would never be allowed under FDA guidelines (hence the gap in the market). While it wasn’t the news we were hoping for, Charisse saved us thousands of dollars trying to create, source and market a product that had no chance of being approved for sale. Her expertise allowed us to focus our time, energy and money into more productive areas.
Greg Giancaterino
Founder of The Goods by Chef Greg
Our company, Fruit & Flower, was hoping to dip a toe into the rapidly expanding cannabis market, but being mostly self-funded, we didn’t have a lot of capital to expend on any false starts, not to mention being over-whelmed by the volumes of rules and regulations. A colleague suggested we call CK Pharmaceutical Consulting Solutions and it may have been one of the smartest moves we’ve made. Charisse from CK Consulting walked us through the complicated rules and regulations and gave us invaluable advice about setting up our manufacturing process and systems. With her help we are on track to launch smoothly and quickly become a viable business in the cannabis field.
Alix Kram
Founder of Fruit & Flower
Charisse and I started at the Food and Drug Administration at the same time and trained together. Over the time we were co-workers, I developed a great deal of respect for her professionalism, her integrity and the depth of her knowledge of the industry. Eventually I left the FDA to start my own clinical consulting business, and I made sure to keep Charisse’s number in my contacts. She has been an invaluable resource when I need more insight or advice about my client’s GMP issues.
Former colleague
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