About Us

Since it’s inception in 2001 IQCDS has been highly regarded for its high level of expertise. Bringing several ex-FDA experts and industry experts together, we can address a wide range of program areas. Our experts can evaluate and address areas ranging from human resources to validation. We particularly can address your quality assurance, production and laboratory needs.

Our average consultant regulatory experience is over 30 years. We provide Consulting Associates with expertise in several technical areas: CAPA, Auditing, Management Review, Risk Analysis, Document Control, Sterilization, Process Validation, Software Validation, Part 11, Stability, Process Mapping, Materials, Training, Human Resources and Laboratories. We also perform project management and develop Compliance Master Plans for companies facing FDA challenges. We have several consultants who are ex-FDA Investigators. We can perform mock-inspections at your facility. We can review FDA 483s and correspondence between you and FDA – making recommendations from ex-FDA and Industry perspectives. Contact us for further information.

About Dennis Saldana

Dennis Saldana started his regulatory career as a Consumer Safety Officer, in the early 1990’s with the Food and Drug Administration in the Los Angeles District Office located in Orange County, California. Mr. Saldana is considered an expert in QSR and GMPs regulations. He conducts audits and developed Quality Systems for Medical Device companies on a worldwide basis. These  include mockup ISO/FDA audits, perform internal/external audits, transferring of Quality Systems and setup of Quality Assurance programs; provide training and support of a variety of internal projects for domestic and foreign companies on a worldwide basis. He assists in and provides guidance in responding to FDA Warning Letters and Form 483 items. Mr. Saldana is actively involved in regulatory compliance audit activities such as QSRs, GCPs, GLPs and cGMPs, for FDA regulated industries. Mr. Saldana participated in the Global Harmonization Task Force effort as an auditor to standardize the audit process within regulatory organizations worldwide.

He was involved as a speaker and auditor in a private, government effort in Taiwan to assess their pharmaceutical, medical device, biotechnology, and veterinary industries compliance status to meet FDA regulations as a result of their worldwide trade independence. He has participated as an invited ASQ speaker to provide perspectives on how to develop an effective CAPA process. He provides training to his clients in many topics related to the FDA, such as “How to Handle FDA Inspections”, “The Effective CAPA Process”, “How to conduct Internal Audits” and many others. During his term with FDA, he conducted many international audits. He was also the Los Angeles Medical Device Team Leader for which he was recognized with an award for his leadership and accomplishments. Mr. Saldana’s experience working with the FDA and with several private medical device/pharmaceutical companies provide him with a unique perspective and ability to effectively communicate with industry as well as FDA in regulatory compliance issues. He acquired a Bachelors in Science, Major in Biology with minor in Chemistry.