FDA Consulting Services for Manufacturing

If you are involved in any type of manufacturing regulated by the FDA, FDA Compliance Group can help.

Our FDA consultants who are all former FDA or have extensive industry experience, can support all phases of the manufacturing process. From single rooms to entire plants, and from design and build out, computer systems to manufacturing and processing equipment, to verifications and validations, we help you improve compliance, quality, and validation.

FDA Manufacturing Compliance Support

Our FDA manufacturing consulting and FDA training services include:

  • Plant design and build out
  • Master and batch record design and review
  • Specification development for components, in-process, and finished product
  • Supplier audits
  • Medical device design history file support under 21 CFR 820.30
  • Dietary supplements product design
  • FSVP and HACCP support
  • MoCRA support
  • Equipment verification
  • Process validation including prospective validation, retrospective validation, and revalidation
  • DQ (Design Qualification)
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Prospective Qualification)
  • Cleaning validation for all industries
  • GMP (Good Manufacturing Practices) support
  • Stability studies
  • Clean rooms
  • Sterility
  • Calibration
  • PM (Preventive Maintenance) and DM (Demand Maintenance)
  • Computer system development and validation
  • ERP (Enterprise Resource Planning) software support
  • Data collection and storage systems
  • Production equipment
  • System software for manufactured products

Validation and Quality Systems

Manufacturing compliance depends on documented, reliable systems. FDA Compliance Group helps companies validate equipment, processes, and software, and we support the procedures and records needed to maintain GMP compliance. For more detail on FDA expectations, see the FDA’s Current Good Manufacturing Practice (CGMP) Regulations. Our team can also help with specifications, records, and change control so your operation remains consistent and inspection ready.

Support for FDA Regulated Manufacturers

We work with manufacturers across FDA regulated industries, including medical devices, pharmaceuticals, dietary supplements, food and beverage, and tobacco related operations. Whether you are building a new facility, expanding production, or improving an existing quality system, our FDA manufacturing consultants provide practical support tailored to your operation.

For more information on FDA consulting services for manufacturers or to schedule a consultation with FDA Compliance Group, please contact us at 303-903-4801.

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