Web Summary
Q1: What is the company name and its focus area?
A1: The company name is Globex Laboratories (R&D) Ltd., and its focus area is on providing innovative solutions for regulatory compliance, quality system, and process validation in clinical drug development and manufacturing.
Q2: What services does GlobeX MRA Consulting offer to its clients?
A2: GlobeX MRA Consulting offers a range of services including Regulatory Compliance, Quality System, Response to FDA observations, Audits, Product Complaints, Risk and Mitigation Strategies, Validation & Testing services, Managed services or staffing to augment existing client team globally, and Project Management / Business Analyst as a Service.
Q3: What is the company's approach to solving regulatory compliance issues?
A3: GlobeX MRA Consulting takes an agile approach to problem resolution, focusing on complex and everchanging GxP Compliance and Regulatory environment. They provide innovative, realistic solutions with a holistic approach to ensure that clients can accelerate problem resolution and cut costs.
Q4: What are the company's focus areas in terms of regulatory compliance?
A4: GlobeX MRA Consulting focuses on Complex and everchanging GxP Compliance and Regulatory environment, providing support for review technical data and submission of documentation to FDA related to NDA, ANDA, and DMF. They also offer services such as Process Validation And Clinical Studies.
Q5: What is the company's approach to quality and compliance?
A5: GlobeX MRA Consulting emphasizes the importance of Quality & Compliance in achieving success in the global pharmaceutical and biotech industry. They provide highquality, cuttingedge, transparent scientific advice for drug development programs across various therapeutic areas.
Q6: Who are the key experts at GlobeX MRA Consulting?
A6: The company has a team of experts in every relevant discipline, with significant capabilities to provide expertise at early clinical development phases for pharmaceutical and biotech drug companies. Their strength lies in their team of experts, who contribute to providing solutions to both simple and highly complex clinical trials.
Q7: What is the company's vision for the future?
A7: GlobeX MRA Consulting aims to partner with clients to drive real innovation, helping them transform and grow their organizations. They strive to emerge as a premiere specialist consulting firm focused on product and process remediation in clinical drug development and manufacturing.
Q8: What sets GlobeX MRA Consulting apart from other consulting firms?
A8: GlobeX MRA Consulting stands out for its unrivaled expertise, wide variety of areas, and personalized approach. They bring in scientific expertise and symbiotic adaptability to successfully execute both simple and complex regulatory, clinical development needs at various translational phases.