Good Manufacturing Practice (GMP) Compliance for Medical Devices & Cosmetics

Ensure Regulatory Compliance and Product Quality with Expert GMP Support

Ensure Regulatory Compliance and Product Quality with Expert GMP Support

Good Manufacturing Practice (GMP) regulations are essential for maintaining product quality, safety, and consistency in the medical device and cosmetic industries. The FDA enforces 21 CFR Part 820 for medical devices and FD&C Act guidelines for cosmetics. Compliance requires robust quality systems, controlled manufacturing environments, and thorough documentation

  • Prevents product recalls and regulatory penalties
  • Ensures safety and consistency of products
  • Facilitates market access and consumer trust
  • Reduces risks of non-compliance and costly disruptions

 

Our GMP Compliance Services provide end-to-end solutions, from facility audits and documentation reviews to training programs, ensuring your operations meet all regulatory requirements

Why GMP Compliance is Essential

GMP compliance is critical for ensuring that medical devices and cosmetic products are manufactured consistently and meet quality standards. Non-compliance can result in:

Our services help you implement robust GMP systems that align with FDA regulations, ensuring safe and effective products that meet market demands

GMP Compliance Services

Key Features of our Core GMP Compliance Services

GMP Facility Audits & Compliance Assessments

Comprehensive audits to assess GMP readiness and identify compliance gaps in manufacturing, packaging, and distribution

GMP Documentation Development & Review

Accurate documentation is essential for demonstrating GMP compliance during FDA inspections and audits

Quality Control & Assurance Program Implementation

Establishing quality control (QC) and quality assurance (QA) systems to ensure product safety and consistency

Supplier Qualification & Supply Chain Compliance

Ensuring that suppliers and third-party manufacturers meet required GMP standards through qualification programs and audits

Employee Training & GMP Awareness Programs

Customized GMP training programs designed to educate employees on regulatory requirements and best practices

FDA Inspection Preparation & Post-Inspection Support

Expert support to prepare for and respond to FDA inspections, ensuring successful outcomes and continuous compliance post inspection.

Why Choose Our GMP Compliance Services?

Specialized expertise

In GMP regulations for 21 CFR Part 820 and FD&C Act

Comprehensive support

From facility audits to inspection readiness

Customized solutions

Designed for medical devices and cosmetic manufacturers

Risk Mitigation

Strategies that ensure market access and consumer trust

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Q. What are Good Manufacturing Practices (GMP)?

GMP ensures that products are consistently produced and controlled according to quality standards that minimize risks associated with manufacturing processes

Q. Who must comply with GMP regulations?

  • Medical device manufacturers under 21 CFR Part 820
  • Cosmetic manufacturers following FD&C Act guidelines
  • Contract manufacturers and third-party suppliers

Q. What happens if a facility fails GMP compliance?

  • FDA warning letters and import refusals
  • Product recalls and market withdrawal
  • Legal action and reputational damage

Q. How often should GMP training be conducted?

  • Initial training for new employees
  • Annual refresher courses
  • Updated training when regulatory requirements change

Q. Why are supplier qualifications important for GMP compliance?

  • Ensures consistent quality of raw materials and components
  • Reduces supply chain risks and regulatory liabilities
  • Supports FDA audit readiness by maintaining traceable documentation

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Our team is friendly, responsive and we love to talk to people interested in what we do. Feel free to get in touch and one of our team will always get back to you. Guaranteed!

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Ensure your medical device and cosmetic operations meet FDA standards with our GMP Compliance Services designed for fast, efficient, and compliant market access

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