Exceptional Consultants, Strategic Solutions
Altabrisa Group LLC is a dynamic U.S. based Pharmaceutical, Medical Device, and Biotechnology Consulting Firm with offices in both United States and Mexico. We provide exceptional GxP (GCP, GLP and GMP) consulting services to clients in the United States, Latin America, Europe, and Asia. Our mission is to provide exceptional consultants and strategic solutions.
While we specialize in Quality Systems and Remediation (483 and Warning Letter responses), and Data Integrity, our extensive consulting capabilities allow us to assist you in meeting your quality, regulatory, laboratory, manufacturing, and validation needs.
Altabrisa Group Limited has worked with many of the world’s leading pharmaceutical, biotech and contract management organizations, including start-ups. We are uniquely positioned to serve life sciences, biologics, biotech, and medical device organizations of all sizes.
Our Tailored Approach to your unique problem means that you get compliance focused, cost effective results.
Our associates have over 20 years of industry experience and come from the best consulting firms in the United States. That means you get the best quality consultants available without Tier I consulting rates.
If you need assistance with FDA Responses, Quality Remediation, Data Integrity Assessments, or just a typical audit, look no further and give us a call. We understand your business. Our proven techniques and methods have resulted in long-term, sustainable results for many organizations.
Build the best product that creates the most value for our customers, use business to inspire and implement environmentally friendly solutions.
We strive to go above and beyond for our clients no matter the challenge. We aim to deliver our very best work every single day across our services.
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Our Life Sciences Practice is composed of International Experts in Pharmaceutical, Medical Device, and Biotechnology. We have experience in the following:
• Quality System Remediation
• Investigations/Root Cause Analysis
• Quality Assurance – Person in Plant (PIP) Responsibilities
• Performing data audits and review (batch records, analytical data, investigations, CAPA’s, Data Integrity, etc.)
• cGMP Audits (Laboratory, Data Integrity, CAPA Remediation and Facility)
• Quality Laboratory Management
• Quality Assurance Management
• Drafting FDA Responses
• Performing Plantwide Investigations
• Deviations Training
• Laboratory, Deviations, CAPA Remediation Coaching & Mentoring
• Quality oversight International Technical Transfer, Performance Qualification, Process Validation and Manufacture by Third Party Manufacturer.