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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

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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:

  • FDA warning letters and import refusals
  • Product recalls and distribution bans
  • Legal liabilities and brand reputation damage
  • Supply chain disruptions and increased operational costs

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

  • Gap analysis reports with actionable recommendations
  • Pre-inspection audits to prepare for FDA reviews
  • Corrective action planning for identified deficiencies

GMP Documentation Development & Review

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

  • Review of batch records and manufacturing reports for accuracy
  • Quality management system (QMS) documentation for medical devices
  • Document control systems to maintain version accuracy

Quality Control & Assurance Program Implementation

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

  • QA systems for process validation and equipment calibration
  • In-process inspections for real-time quality monitoring
  • Deviation and non-conformance management procedures

Supplier Qualification & Supply Chain Compliance

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

  • Audits for contract manufacturers and raw material suppliers
  • Ongoing performance monitoring and compliance reviews
  • Document verification for supplier certifications and approvals

Employee Training & GMP Awareness Programs

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

  • GMP fundamentals training for all operational staff
  • Refresher training sessions to ensure up-to-date knowledge
  • Certification programs to document employee competency

FDA Inspection Preparation & Post-Inspection Support

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

  • Mock FDA inspections to identify potential compliance risks
  • Remediation strategies to address inspection findings
  • Post-inspection compliance monitoring for ongoing readiness

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

Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.
Jane Mckay
Jane MckayAstute Beverages
I had hit a brick wall trying to get my FDA number for export of my rum to the USA. Ryan and James knew all the right contacts to sort this out for me. I could not have done it without Global Import Agent. They even sorted out my prior notification paperwork for me. I can highly recommend them.
James Singlehurst
James SinglehurstRevival Rum
Ryan, Chris and their team were exceptional in getting our food supplement product FSVP compliant. Pretty good experience with Global Import Agent overall.
Kelvin Yeo
Kelvin YeoAdvagen
Great level of service in the 3 months we have been working with Global Import Agent to date. From the first call with Fabrizzio to the comms with Ryan, James & Carlos, all has been good and the progress we are making is fantastic!
Jeff Webster
Jeff WebsterHunter & Gather
I recently had the pleasure of working with Ryan and his team for a label review of a dietary supplement, which was intended for commercialization in the United States. My experience was overwhelmingly positive, as they provided exceptional and professional support throughout the process.
Renato Di Lorenzi
Renato Di LorenziLoli Pharma
We use Global Import Agent as our FSVP agent for importing dietary supplements into the US from the EU. They've provided us with professional high-quality service thus far. Recommend!
Keiu Kadarik
Keiu KadarikEcosh Life
We were a start up working on our first import, and Global Import Agent was superb in taking care of our documentation and import process. Highly recommend.
Hee Joong Kim
Hee Joong KimMuom Life
Ryan is very helpful from the beginning to end. He responds super fast and he is on point to the issue / objectives.
Wonsik Woo
Wonsik WooLifeLab
James, Ryan and Carlos have been really helpful all along our FSVP. Great service.
Anahi Cabrera Herrera
Anahi Cabrera HerreraScience In Sport
Flexible and helpful FSVP agent. After comparing a couple of agents, this one is the one we picked. No regrets!
Andreas Edström
Andreas EdströmSwedish Signature AB
they are fast, efficient, and always open to help. They have been a great support for me and my company
Alba Rodríguez
Alba RodríguezGricha
Great to deal with, cost efficient and professional, highly recommended
Stephen Goument
Stephen GoumentGolden Turmeric
​What our clients say

Client Feedback

Read what our clients have to say about our services and how we have helped them export product.

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

Want To Ask Something?

We are always ready to answer your questions

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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