Empowering Success through Regulatory Affairs and Quality Assurance
Our Specialties
New Product Development
Project team liaison throughout the entire product life cycle phase.
Strategy Planning
Global regulatory strategy techniques specialized for several markets.
Technical Files & STED Design
Class I, lla, llb, and lll technical file management with MDD to MDR STED compliance.
Project Management
Project management skills to initiate, execute, and control most complex projects.
QSMR
Assist with compliance of FDA’s Quality Management System Regulation (QMSR) harmonization.
Internal/External Auditing
ISO 13485 Auditing of your Quality Management System.
Database Management
Maintain your current product portfolio’s compliance through proper database management.
Global Product Registrations
US, EU, Canada. LATAM, AsiaPac and EMEA Distribution
Who are we?
Lindsey Regulatory Affairs Consulting, LLC (DBA, LRA
Consulting) strives to meet the clients needs in every way.
LRA Consulting was created in 2018 with the goal of providing excellent regulatory affairs services customized to meet the needs of clients. We are a full-service regulatory consulting group capable of guiding clients throughout the full product lifecycle. Whether you are a start up company or well-established enterprise, we can provide services at any stage. Our team of knowledgeable consultants with over 30 years of combined experienced, can provide support with domestic and international regulatory strategy, project management, submissions, and overall regulatory compliance.
Let us assist you with bringing new technologies to the market while maintain your current product portfolio’s compliance to industry standards.
Purpose
Vision of LRA Consulting
To cultivate a dynamic Regulatory, Quality, and Clinical consulting experience.
Mission of LRA Consulting
To provide a simplified approach to exceptional consulting services for the medical device and pharmaceutical industries.
Compliance Needs
Don’t let your regulatory compliance fall behind, let our team of knowledgeable experts assist you. With experience in markets including the US, EU, Canada, LATAM, AsiaPAC, and EMEA; LRA Consulting can help you deliver your product all over the world! Contact us today to see how we can help with your Regulatory and Quality needs.
Success