At MR, each project is assembled with a team of skilled professionals with engineering, science or computer sciences degree. In addition, our team has a strong hands-on technical and scientific experience, obtained from previous projects such as complex and largest industrial and remediation projects inPuerto Rico, United States, Santo Domingo and Mexico. Our consultants work closely with your team to understand and meet the goals of the project; following a risk management execution approach. We also hold depth knowledge in cGMP and regulatory manufacturing practices to overcome challenges with innovative and cost effective solutions.
Team bring cost and schedule certainty through well understanding of the Product Life Cycle and expertise obtained from previous complex projects including Remediation projects
Professional Staff & Expertise
Staff
• Project Managers/Leads
• Quality Assurance
• Quality Control
• Regulatory Specialist
• Auditors
• SR. Validation Specialist
• Scientist
• Validation ENgineers
• CSV/ IT Validation Specialist
• Manufacturing QC
• Investigations
• Capa
Expertise
• Solid DOSAGE: master Plans, start-up, mechanical completion, COMMISSIONING Equipment Qualifications, Process & Packaging Validation, Cleaning VALIDATION, Remediation Projects, cGMP Facility Audit
• Fill & Finish/ Bulk Manufacturing, COMMISSIONING Utilities & Equipment Validation, Serialization, CSV, Delta V, LIMS
• Biotech & Parenteral: Turnover (TOP) Packages COMMISSIONING Validation, Process IMprovements, cGMP fACILITY aUDIT
• Continuos Process Improvements