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Consultants

Our team of product development and regulatory experts harnesses a breadth of federal and commercial regulatory experience and extensive scientific knowledge to design and implement efficient drug and medical device development programs for clients around the world. In addition, these Expert Consultants serve in advisory capacities to support your regulatory and development needs throughout your product’s lifecycle.

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Richard Aleman

Expert Consultant

Functional Area Focus

  • GMP Audits
  • Quality Systems
  • Regulatory Compliance

Product Area Focus

  • Biologics
  • Drugs
  • Medical Devices

Biography

Mr. Richard Aleman joined ProPharma Group as an Expert Consultant in 2021. He was formerly Director of the Field Activities Branch at FDA, where he was responsible for the Investigation and Compliance Branch regarding investigative, inspection, and compliance activities for biopharmaceuticals, drugs, and medical devices. Following his 28-year FDA career, Mr. Aleman served as Vice President of Regulatory Compliance at Pharmatech Associates Inc. (PAI), and in Director of Compliance roles at Vintage Pharmaceuticals and Cardinal Health (formerly Adams Laboratories). He also served as a United States Pharmacopeia (USP) Consultant and Lead Auditor for international assignments in Asia, South America, Europe, and North America.

Mr. Aleman is an expert in regulatory, compliance, and enforcement issues, and for conducting cGMP internal and external audits, including Finished Pharmaceuticals, Active Pharmaceutical Ingredients (API), Excipients, and Dietary Ingredient and Supplement manufacturers, to assure conformance with established guidance and regulatory requirements, both domestically and internationally.

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Contact an Expert Consultant for Help Navigating the Dynamic Regulatory Market

Our Expert Consultants can assist you with custom solutions, whether you have an ad hoc regulatory challenge or need an experienced partner to design and execute a successful development program for your pharmaceutical, biologic, or medical device. Complete the form or call us at 540-738-2550 to learn how our team of experts can help you.

Tell us a bit about your challenge(s) so we can connect you with the appropriate experts who can help.

 


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