FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

Drugs / Pharmaceuticals ~ FDA Consulting Services

At FDA Compliance Group, our FDA consultants have all worked for the FDA or have extensive drug / pharmaceutical experience.

We are a full-service consulting firm, offering assistance in all aspects of FDA compliance and FDA regulations.

FDA cGMP Compliance Audits and Gap Analyses
We can assess the level of FDA compliance of your manufacturing, quality, and laboratory systems (with 21 CFR Parts 210 and 211, as well as other applicable FDA regulations) and counsel on the steps needed to fully comply with FDA requirements for drugs / pharmaceuticals. We perform due diligence audits, cGMP audits, Quality Operations (QC / AQ), mock pre-approval FDA inspections, R & D portfolio, Business Analysis Manufacturing scale-up, formulation SAS, and Bioequivalence.

FDA Inspections and FDA Warning Letters
We can direct you through the complicated process of providing an adequate response to an FDA Form 483 (Inspectional Observations) or an FDA Warning Letter for drugs / pharmaceuticals. Often, a well-constructed 483 response or FDA Warning Letter response can preclude additional regulatory action by the FDA. We can also provide assistance with FDA inspections, from audit preparation and training to onsite support during the inspection, or any other FDA inspection services you may need.

FDA Adverse Events
We can confirm that your record keeping and S/AER (Serious Adverse Event Reporting) is in full compliance with FDA requirements and regulations for drugs / pharmaceuticals. In case of a product recall or other regulatory action, we can provide best practices advice for steps that need to be taken.

FDA Specifications, Procedures, and Documents
We can write and help you implement cGMP compliant procedures, work instructions, and protocols, that are customized to your products and processes.

We can assist with "crisis management" plans, and we specialize in Out-of-Specification (OOS) investigational report preparation and for drugs / pharmaceuticals.

FDA Research and Development
We provide project management services and strategic planning for all aspects of pharmaceutical R & D that are regulated by the FDA, including assessment and counsel for: analytical and bioanalytical development; CMC (Chemistry And Manufacturing) stability, Master Batch Records, Executed Batch Records, and deviation reporting.

FDA Qualification / Validation
We qualify and validate all of your processes, procedures, and equipment, and make sure that they are adequately documented, in areas such as: finished product testing, weighing and blending operations, facility and equipment cleaning methods, and IQ, OQ, and PQ. We also qualify and validate computer applications for 21 CFR Part 11 compliance, including data collection and storage systems, ERP software, laboratory information systems, and more.

For more information on FDA consulting services for drugs / pharmaceuticals or to schedule a consultation, please contact us.