TRAXN Consulting provides regulatory affairs services to the medical device industry, covering a wide range of companies, devices and submission types. From strategy through execution, TRAXN Consulting can help you get your product to market and keep it there.
11 Compliance Consulting offers subject matter expertise on quality systems management, with a concentration on compliance to 21 CFR Part 11 and Annex 11 requirements. Our primary emphasis is providing implementation guidance from purchase to deployment of your next EDMS, LMS, or QMS.
Since 1995, MWA Consulting, Inc. has successfully partnered with clients worldwide to meet and exceed their regulatory compliance requirements and guidelines. MWA provides exceptional compliance consulting expertise from development through commercialization for the pharmaceutical, biotechnology, cosmetics, dietary supplements and medical device industries. We are a trusted and reliable choice for your GCP, GLP, and GMP compliance consulting projects, training and audits.
Ticalion is the first and only company to offer beginning to end FDA and ISO 9001 compliant Quality Management as a Service. We are a team of FDA and ISO quality management professionals, delivering end-to end quality management services as an alternative to the mix of in-house employees and temporary consultants.
Consulting firm for pharmaceutical industry and their suppliers. Focus on pharmaceutical development, manufacturing, quality management with particular emphasis on computer system validation.
25 years of experience in the clinical development of investigational therapeutic and diagnostic products for pharmaceutical, biotechnology, medical device and diagnostic companies.
Consulting firm specializing in quality, FDA compliance, system selection, architecture and design, implementation, enhancement and maintenance. Primarily focused within regulated environments with laboratories.
Provide Quality Management System consulting which includes creating procedures and forms, internal audits, supplier audits, and hosting regulatory audits and remediation if necessary.
Paul Fredriksen is a quality systems and quality auditor for medical devices and related quality systems. Pauls provides tailored courses for auditors, quality system regulations, risk. FDA inspection survival helper.
Digital Quality Associates are an innovative company offering cutting edge consultancy services in strategic quality leadership, compliance consultancy, audit/ inspection and training. A key skillset that resides within DQA is providing its clients with peace of mind that their digital health projects are compliant and inspection ready.
