Compliance Certification
As your dedicated partner and consulting expert, we deeply understand the intricate processes and regulatory challenges faced by manufacturers industries.
GMP / FDA Certification
If you are considering doing business in the supplements industry then you definitely need to know about GMP Certification. Without a true GMP Certification, you cannot have a successful business selling supplements for human ingestion.
The FDA currently monitors the entire supplement industry and they are doing this monitoring very closely. With more people becoming more aware of their bodies and the role that their nutrition and wellness plays in their health, they are becoming more open to supplementation.
As the industry continues to grow in popularity with more companies coming on stream and more consumers purchasing and consuming supplements, the FDA has beefed up their monitoring in an effort to ensure that end-users are getting only the best quality products. As such compliance is essential to success in the industry.
GMP certification for dietary supplements is offered by a number of global certification bodies. What is GMP certification anyway, what do the letters stand for?
Non-Conformance & CAPA Management
Our quality, manufacturing, CAPA, and supplier quality experts conduct comprehensive process reviews and analyses to ensure all compliance gaps are closed no matter where they may be.
- Non-Conformance/Deviation Investigation Management Support
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Process Analysis & Enhancement
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Investigation, Action Plan, & Effectiveness Check
Quality Assurance & Compliance
Quality Management Systems (QMS)
Concerned your quality system doesn’t reflect FDA expectations? Connect with former FDA and industry professionals who have extensive knowledge of FDA’s current inspection techniques and expectations that go beyond the words of regulation. Through mock FDA audits, remediation support, and resourcing for your quality system, you can make the appropriate adjustments to meet all FDA regulations.
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GxP Audits
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QMS Process & Procedure Development
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Gap Assessments
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QMS Remediation
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Quality Unit Resourcing
Regulatory Compliance
Move your organization forward while maintaining a continuous and complete state of regulatory compliance. From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any regulatory challenge.
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Regulatory Observation/Warning Letter Responses & Remediation
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PAI & Inspection Readiness
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Internal Audit & Remediation Services
Medical Device Compliance
At cGMP Consulting, we understand the importance of maintaining regulatory compliance for medical device manufacturers. With over 20 years of experience, we’ve honed our expertise in delivering high-quality, safe, and compliant solutions tailored to each client’s unique needs while meeting the highest standards.
Our consulting services encompass a wide range of subjects relevant to medical device manufacturing such as:
- Quality Assurance and Control
- Equipment Qualification
- Process Validation
- Documentation and Record-keeping
- Risk Management
- Supplier Qualification
We take pride in not just meeting regulatory standards but also driving business excellence. Our engineering team will work closely with your team to develop the desired scope, deliverables, and timeline to suit your needs. We provide valuable insights and guidance, ensuring that your medical device manufacturing operations are not only compliant but also efficient, reliable, and competitive.
Together we will mitigate compliance risks, optimize operations, and achieve sustainable success in an ever-evolving, highly regulated industry.
Rest Assured, You or Your Company is Covered
At Kansai Solution, we prioritize your peace of mind by ensuring that your operations meet all regulatory and compliance requirements. From environmental standards and worker safety regulations to industry-specific guidelines, our experts provide comprehensive assessments and actionable solutions to keep your business fully compliant. We stay up to date with evolving regulations, such as OSHA, EPA, REACH, and ISO standards, so you can focus on growth while we handle compliance complexities with precision and dedication.
Why Choose Us
At Kansai Solution, we don’t just offer services — we deliver results driven by innovation, expertise, and an unwavering commitment to excellence. With decades of experience, a deep understanding of industry standards, and a customer-focused approach, we provide tailored solutions that empower your business to thrive. Trust us to be your partner in success, ensuring quality, compliance, and efficiency at every step.
Industry Expertise
Tailored Solutions
Regulatory Compliance
Innovative Approach
Cost and Time Efficiency
Objective Perspective
