We are an experienced professional consulting firm offering proven practices in Quality Systems, Validation and Compliance to provide confidence and control of the regulated processes involved in the manufacturing and distribution of Pharmaceutical / Life Science, Medical Devices and Food products.
• Efficient and proven compliance best practices.
• Compliance requirements grounded on risk assessment approach.
• Experienced and Reliable Project Managers & GMP Consultants.
• Cost and schedule certainty.
We can help.
Whether you need specific expertise and or are staff-limited, LMR Industrial Compliance can offer the professionals or team you might need.
We are enthusiastic about collaborating with you!
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How we Work
Offer multi-discipline professionals with over 16+ years of experience capable to apply rigorous Quality Standards and to recommend the best Criterias and Solutions to evidence compliance of:
• Solid Dosage Form & OTC
• Parenteral/ Aseptic Areas
• Biotechnology
• Bulk Chemical Plant
• Medical Devices
• Food/Beverage & Cosmetic
Provide guidance on meeting FDA regulatory requirements as well as other international health regulations through the Product Lifecycle, and applying latest trends such as risk management:
• Quality Assurance & Regulatory
• Quality Systems
• Start-up & Commissioning
• Validation Lifecycle Program
Founder
MEET
María López
I have worked for the past twenty-five years in the Life Sciences regulated industries as director and manager of Consultant Services contractors firms such as: Raytheon & Flour; and as former employee of the pharmaceutical industry (Abbott, Schering) in the Quality Assurance and Quality Control areas.
Overall experiences provided me well knowledge in Product Lifecycle: Design, Construction, Start-up, Turnover, Manufacturing, Quality Assurance, Quality Control, Microbiology, Quality Risk Assessment, Validation Programs and Remediation Projects. I’ve been focusing my career in establishing solid project execution strategies, select and assign the best consultant staff, anticipate the project-business needs and take actions based on impact (quality/time/cost).
I attended the Colegio de Agricultura y Artes Mecánicas de Mayagüez, Puerto Rico, and graduated with a degree in Natural Sciences with major in Industrial Microbiology.