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Melita Ball

MBC & Affiliates, LLC
Regulatory & Quality

Contact Information:

2016 W Silver Rose Pl
Tucson, AZ 85737
United States
T: 520.665.9081
F: 480.247.5169
www.mbcaconsulting.com

Years in Business:

 

7

Clients I'm Seeking:

 

I'm seeking Life Science clients that are looking for Regulatory Compliance and/or Quality System help.

About My Business:

 

MBC & Affiliates, LLC is a full service Quality System and Regulatory Compliance consulting firm dedicated to Life Sciences organizations. We have real-world experience and a team of specialists that work together to deliver consistent results to our clients across the globe. Our consultants average experience level is 24 years. We consistently work with Life Sciences companies to improve quality, compliance, and overall performance. Our Model for Success:  Long term relationships with our clients  Consistent, practical advice that works for our clients' businesses  Ability to improve an organization's standing with the FDA Services Include:  Regulatory Compliance support • FDA Inspection support • 483 response • Warning Letter response & mitigation • Remediation support  Quality Auditing & Assessments • Internal Audits & Assessments • Supplier Qualification Audits  Quality System Design, Re-engineering, & Implementation • FDA 21 CFR Parts 11, 210, 211, 801, 803, 806, 820, & 880 • ISO 13485 & 14971 • SOR 98-282 Canadian Medical Device Regulations • MHLW No 169 (JPAL - Japanese Pharmaceutical Affairs Law)  Software Configuration, Validation, & Implementation according to industry standards and Part 11 requirements  Regulatory Compliance Training • Quality System Basics Training • Executive Management Responsibility Training • Job-Specific training for Compliant Handling, Design Controls, CAPA, Production & Process Controls, Document Controls, Purchasing Controls, QA/QC, Nonconforming Product, Installation, and Servicing • Internal Auditor and Lead Auditor Training • Custom courses can be developed for your specific needs  Regulatory Affairs Services • Registration & listing • 510k submissions • PMA submissions & supplements • Product licensing • Regulatory strategy  Clinical Services • Clinical Trial management • IRB reviews • Clinical document writing • Custom clinical databases • Clinical protocols • Clinical Study design and strategy  Technical & Engineering Services • Quality Engineering • Sterilization Validation • Stability Testing • Design Control Engineers  Overall Project Management available with any service

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