Consulting Services

Our average consultant regulatory experience is over 30 years. We provide Consulting Associates with expertise in several technical areas:

  • CAPA
  • Process Validation
  • Training
  • Auditing
  • Software Validation
  • Human Resources
  • Management Review
  • Part 11
  • Laboratories
  • Risk Analysis
  • Stability
  • Document Control
  • Process Mapping
  • Sterilization
  • Materials

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.

Renowned for their expertise and depth of experience, our consultants are in high demand worldwide. Since starting the consulting practice of Saldana & Associates in 2001, the practice has grown along with its reputation for getting the job done. With more than half of our consultants being ex-FDA experts, we are especially suited for consulting the FDA regulated industries on many of the urgent matters you are facing. These experts are primarily compliance and quality system related experts.

We can work on-site with you to develop or improve numerous GMP or Quality System areas. We bring expertise to such areas as document control, CAPA, auditing, management review, validation, laboratory controls, training and complaint handling. Our product expertise lies in medical devices, including IVDs and pharmaceuticals. We also assist biotech and API manufacturers.

Our consultants can assist you in reviewing or writing a Compliance Master Plan, or any other document that is important to GMP or quality system compliance. Whether the project involves setting up a CAPA or management review program or a complete gap analysis and establishment of a validation master plan, we can assist. Aside from our associates listed in the Industry Experience section we utilize tried and proven expert consultants in areas ranging from software and validation to process improvement areas including process mapping and scorecard.

We also can bring project management staff on site that can develop and maintain software packages to guide you in compliance projects. We can add strength to areas that you may be weak in. Our goal is not to enter into lengthy consulting projects, but rather to get you involved in establishing and maintaining an adequate and effective quality system. We want to get you going in a manner that is not dependent on consultants. Yet often that jump start is needed in many areas of the quality system. We will work with your staff to get you going and, as soon as possible, leave you alone to do your job.

To discuss possible on-site consulting initiatives please contact us at (949) 235-6037 or email us at info@iqcds.com.

Mock FDA
Inspections

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Compliance
Master PLans

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Targeted Quality
System Improvements

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Internal & External
FDA Audits

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FDA Warning
Letter Response

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Revamp
FDA SOP

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Design Controls
Program

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Complaint Evaluation,
Documentation & Validation

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Employee FDA
Competency Evaluation

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Client Recognitions & Endorsements

We are extremely grateful for the recognitions & endorsements of our clients and we hope to include you among them.

1995 Letter of appreciation for my quality and professionalism from Regulatory Affairs Consultant, Glen A. Dunki-Jacobs. (Phacoemulcification Devices)

Regulatory Affairs Consultant

2009 Letter of recommendation from Johnson & Johnson, for providing compliance consulting services.

Johnson & Johnson

1999 Letter of appreciation from Medtronic Anurex facility. As a result of my audit the facility passed a FDA pre-PMA inspection without FDA-483s.

Medtronics Anurex

1993 Letter of appreciation for my thorough and probing investigation from Pegasus Research Corporation, President, Kenneth G. Miller. (Humidifiers)

Medtronic Heart Valves

2007 Letter of appreciation for an excellent job in identifying weaknesses in company system, providing constructive solutions, clearly explaining the FDA interpretations of various clauses in the regulations, and allowing the staff to experience the interviewing techniques of a FDA investigator. Staff was comfortable with his conversational and interviewing style.

Need Company

2009 Letter of recommendation from ASP for consulting services related to performing a comprehensive gap analysis and redesign of company’s Design Control process.

ASP

1986 Outstanding Young Men of America for religious and professional contribution at the University of Puerto Rico, Regional College Administration, submitted by Jorge Valentin, Dean for Student Affairs.

University of Puerto Rico

1995 Letter of appreciation from Patrick Bouveret, Plant Manager for my quality and professionalism from Laboratory Prodimed, France (Endometrial Suction Curette).

Laboratory Prodimed

1997 FDA Cash Award for exceptional service as a Team Leader, for performing several high priority PMA/510(k) assignments and for my participation with the Global Harmonization Task Force auditing cadre.

Global Harmonization Task Force

1997 Letter of commendation from Willy Rusch, Germany, for my thorough inspection and extremely thorough analysis and grasp of their processes (catheters).

Willy Rusch

2003 Letter of recommendation from Guidant Co. (Catheters/Drug Delivery Systems)

Guidant Co.

1995 Letter of appreciation for my commendable performance from Instrumentation Laboratory, Italy, Vice President/Quality Assurance, World Wide, James C. McGaha, Jr. (IVDs).

Instrumentation Laboratory

1995 Letter of appreciation for my valuable information from Venusa, Ltd, Italy, President /CEO, Cesare Gagliardoni (IV Sets).

Venusa, Ltd.

International Quality Consulting bring a diverse team of consultants to our clients. We are constantly expanding our roster of internationally recognized associates. Our trainers and consultants average over 30 years experience in the FDA regulated environment – many of which are ex-FDA. Our associates bring a wealth of experience to help meet your consulting and training needs.

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