FDA Regulatory Consultants
Comprehensive Compliance Solutions (CCS), LLC offers a broad spectrum of support and regulatory compliance assistance to industries regulated by the U.S. Food and Drug Administration. Our seasoned experts are former FDA executive-level officials with an average of 35 years of FDA regulatory experience in conducting inspections across the full range of FDA regulated industries. CCS is qualified to work with large corporations as well as small businesses that manufacture biological products, cosmetics, foods, medical devices and; human and veterinary pharmaceuticals.
Keywords: FDA Regulatory Consultants,Regulatory Consultants, Regulatory Affairs Consultants, cGMPs, product quality, pharmaceutical manufacturing, new drugs, Rx and OTC drugs, drug labeling, product surveillance, devices, biologics, imports, exports, adverse drug experiences, recalls, bioresearch monitoring, export certificates, regulatory compliance, risk management, quality systems, FDA enforcement, U. S. Agent, expert witness, regulatory submissions, validation.
Interview Q&A
How long have you been in business?
Comprehensive Compliance Solutions, LLC has been in business in the Washington metropolitian area since December 2004.
What is your primary product or service?
Comprehensive Compliance Solutions (CCS) offers a broad spectrum of support and regulatory compliance assistance to industries regulated by the U. S. Food and Drug Administration (FDA). Our seasoned experts are former FDA executive-level officials with an average of 35 years of FDA regulatory experience in conducting inspections and achieving compliance solutions across the full range of FDA regulated industries.
CCS is qualified to work with large corporations as well as small businesses that manufacture biological products, cosmetics, foods, medical devices and; human and veterinary pharmaceuticals.
How did you first become interested in your line of business? (if owner) - What is your background? (If owner or store manager)
Comprehensive Compliance Solutions (CCS), LLC was founded in 2005 by Dr. Betty Jones, former Deputy Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research and Ms. Sandra N. Whetstone, former Director of the Division of Compliance Management and Operation, Office of Enforcement in the Office of Regulatory Affairs of the U. S. Food and Drug Administration.
How do you differentiate yourself from other businesses in your category and area?
Our science-based backgrounds coupled with a breadth of FDA experience working with industries that manufacture and market FDA regulated products qualifies us to help you stay in compliance throughout the life cycle of your product. We are committed to helping your business succeed whether your company is global or a start-up company.
How many locations do you have and do you have plans to expand?
We currently have two locations with the primary business office being located at 3006 Ivy Bridge Road, Fort Washington, MD 20744.
Provide detailed directions to your location
CCS primary business office is located in Prince Georges County between Bock Road and Allentown Road.
What type of payments do you accept?
We except cash, checks, wire transfers and credit cards.
Which areas do you service?
cGMP compliance, quality systems, imports & exports, CAPA, standard operating procedures, product labeling, product advertisement and promotion, regulatory submissions, Gxp audits and inspections, regulatory correspondence & responses, product registration and listing, food facility registration, expert witness/testimony, bioresearch monitoring, product recalls, validation, seminars and training, U.S. Agent and Freedom of Information Services.
Who owns your company or runs daily operations?
Comprehensive Compliance Solutions (CCS), LLC is co-owned by Dr. Betty Jones and Ms. Sandra Whetstone.
What are your hours of operation?
CCS's hours of operation are 8:00 a.m. - 4:30 p.m. Monday -Friday.