About Us
- A vision for the future can’t be realized without know-how. We partner with our clients to drive real innovation—the kind that turns an idea into an industry—helping them transform and grow their organizations.
- GlobeX has emerged as a premiere specialist consulting firm focused on product and process remediation in clinical drug development and manufacturing including INDs to ANDAs
Our agile work principles have gained us recognition and respect amongst the peers and stakeholders, as it sprouts from extensive scientific acumen and years of cumulative team experience. We have satisfied our clients through our high quality, cutting edge, transparent scientific advice for their drug development programs across various therapeutics areas.
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01 At GlobeX
At GlobeX, experts with proven remediation experience across dozens of projects at Global F500 Pharma and Biotech leaders can accelerate problem resolution and cut costs, with fees well below traditional consulting forms with generic focus and lesser skills.
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02 Our Focus
We are focused on Complex and ever-changing GxP Compliance and Regulatory environment which leads to inevitable approval problems at various stages that can halt development, threaten time to market, and very expensive to resolve.
GlobeX MRA Consulting Focus Areas
• We provide innovative, realistic solutions with holistic approach
Compliance: cGMP and Quality System, Response to FDA observations, Audits, Product Complaints, Risk and Mitigation Strategies
Regulatory: Provide support to review technical data and submission of documentation to FDA related to NDA, ANDA and DMF
Validation & Testing services: Manage and Provide Technical support & services in the area of Process Validation And Clinical Studies
Extended Services: Project Management / Business Analyst as a Service, Managed services or staffing to augment existing client team globally
Resourcefulness, rationality, transparency and ethics
Services
GlobeX exclusively focuses on product and process remediation in clinical drug development and manufacturing including INDs to ANDAs.
We bring in unrivalled expertise in wide variety of areas helping us support end to end needs integrated with personalized approach.
GlobeX's scientific expertise and symbiotic adaptability allows for successful execution of both simple and complex regulatory, clinical development needs at various translational phases directed to generate organic, innovative and holistic solutions.
GlobeX team has proven remediation experience across dozens of projects at Global F500 Pharma and Biotech leaders can accelerate problem resolution and cut costs, with fees well below traditional consulting forms with generic focus and lesser skills
- API Supply Resource Center and Services
- Gap Analysis and Risk Assessment
- Mock Audits and PAI readiness
- CMO/CRO/Supplier Audits
- Data Integrity Evaluation, Assessment and Remediation
- Response to FDA Warning Letter & Consent Decree, Assessment and Remediation
- Investigations and GxP Training
- Project Management - CMO/CRO Projects, Preclinical and Clinical Studies
- Method Development & Validation – Assessment and Remediation
- IT Services - Computer System Validation and Technology Transfer
- New Product, Technology Assessment and Licensing
- eCTD filing preparation and support
Our Team
We bring experts in every relevant discipline to each client’s challenge. The value they deliver goes deeper than their resumes. .
We have toiled to persistently take steps to improving our extent of expertise and scientific acumen. This has enabled us to assist in providing solutions to both simple and highly complex clinical trials across several therapeutic areas. We have significant capabilities to provide expertise at early clinical development phases for pharmaceutical and biotech drug companies.
Our strength is our team of experts!
These team members are core of the company, contributing and promoting our visionary prospective thinking and team-based learning culture. Utmost importance is given to scientific innovation, meticulous attention to details and dynamic quality improvement with high priority approach to safety and outcomes with time in control. Our innovative, rationale and out of the box thinking coupled with scientific temperament can make a significant difference to the outcome of the clinical development programs for our collaborators and partners.
Leadership
Case Studies
Novartis, NJ site: Site Closure and GMP compliance: Established a brand new Stability Testing Analytical Lab as per GMP and Safety requirements in just 6 months. Impact: Met the timeline, established GMP operation, and approved by FDA
Dr. Reddy Lab, Vizag, India: FDA Warning Letter: Provided expertise to prepare response letter to FDA Warning letter. Product Quality Assessment (PQS) – Gap Analysis and Remediation work over 6 months. Impact: FDA lifted import alerts, product released to market in the US.
Bayer, Germany: FDA Warning letter. Data integrity assessment, review empower data for 5 years, Gap Analysis completed, BRR and implemented CAPAs and Remediation efforts completed successfully. Impact: FDA lifted import alerts, product released to market in the US.
DIVIS Lab, Vizag, India: FDA Warning Letter: Provided expertise to prepare response letter to Warning Letter, PQR, Data integrity Review, Computer System Validation Reviews, Empower data review, 9 months efforts, impact: FDA lifted import alerts for the products and issued no observations, cleared Warning letter. Enhanced GMP and Compliance, Allowed to sell the APIs and Intermediate products to major Pharma companies in USA and Europe. stock price doubled
Vertex Pharmaceuticals, Boston: Clinical Study Data Integrity: Performed Gap Analysis and Data Integrity assessment, implemented CAPA plans and remediation efforts; Verified Clinical Empower DMPK data over 18 months. Impact: Certified GLP/GMP compliance, FDA visited and sited no observations
IPKA, India and Wackhard, India – FDA Warning Letter. Worked as part of the team to provide the response to FDA warning letter. Impact: FDA lifted import alerts for clinical products and Orphan drugs
Collaborations
We strongly believe in collaborations and partnerships. We are committed to building successful collaborations bringing value to each partner. We are collaborating various academic and industry partners.
Contact
Feel free to drop a mail or call us with your queries
Location:
GlobeX MRA Consulting ,
3 Slater Ct,
Hillsborough, NJ 08844
Email:
mahender@globex-usa.com
Call:
908-938-3351