A Professional Support for No Delays or Compliance Gaps
It is vital that medical device companies maintain proper data integrity during the manufacturing process of any medical device. Our experts at Elexes Medical device Consulting will help you adhere to all the standards issued by the global regulatory bodies and will help you stay within the cGMP while preserving your data’s integrity.
With the set of services we offer and the consulting process we follow, you can rest assured that all your regulatory regulations and compliance issues are addressed professionally - including cGMP manufacturing compliance and medical device’s data integrity.
Our cGMP & Data Integrity Training Services
We, at Elexes, one of the most trusted medical device consulting companies have a proper and well-established training module that ensures proper compliance to both cGMP and data integrity regulations set by global regulatory bodies. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Our cGMP training program includes
Our Compliance Assessment Process
Our team of regulatory experts is well-versed in global cosmetic packaging regulations and has a proven track record of ensuring compliance.
We understand that each cosmetic product packaging is unique. Our solutions are tailored to your specific needs.
Why Choose Elexes?
We work diligently to provide timely results, ensuring your products' packaging meets compliance requirements promptly.
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
We handle your product and packaging information with the utmost confidentiality and adhere to strict privacy standards.
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
Amazing Feedback Say About Services
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York