NexDox is a biopharma-focused startup offering an AI-based, no-frills documentation and guidance generation platform. Their solution streamlines tasks like data entry, record keeping, and document generation, enhancing efficiency and accuracy within the industry. By automating repetitive processes, NexDox enables biopharma professionals to focus on critical aspects of drug development and regulatory compliance.

Global Compliance Partners was founded by engineers with many years of experience in the Biotech & Life Science Industry. GCP prides itself in technical excellence, management acumen and quality of service.We distinguish ourselves from our peers with our ability to build efficiency in business and technical problem solving. Our team thoroughly understands the compliance and validation needs of clients and implements lean risk based approaches towards all projects.Areas of expertise include CAR-T cell therapy, Viral vector and Gene therapy, Process Validation, Equipment and CSV Validation, BLA/audit support, CPV programs, Data Integrity support and Project Management

Leading Capital Projects at Genentech and Boehringer Ingelheim.Principal Validation lead for upstream, downstream, utility and CSV systems involved in development of URS, system impact and criticality assessments, IQ/OQ/PQ documentation and validation summary reports.Project lead providing expertise in risk analysis, GMP validation and resource planning.Demonstrating leadership in a dynamic cross functional team setting, in meeting project milestones and in creating project road maps.Reviewing project proposals for accuracy of technical details and budget requirements.Partnering with Process Maintenance, Facilities, Automation, Quality Assurance, Engineering, Manufacturing and Instrumentation Services for project co-ordination & implementation.

• Lead teams of consultants for clients such as Amgen, Genentech, Novartis and Sanofi Aventis.• Certified Continuous Improvement (CI) Practitioner - Implemented Lean Six Sigma methodologies, 5S and Kaizen at different client sites.• Developed methodologies to reduce budgets, optimize delays and improve quality oversight using CI practices.• Directed and managed multiple capital projects for a wide range of systems and equipments across different teams.• Championed CI projects by process mapping and conducting value/non value assessments, root cause analytics, fish bone analysis, Pareto analysis and Failure mode &Effect Analysis (FMEA).• Proactively managed changes in project scope, identified potential crises and drafted deviation and mitigation plans.• Actively involved in Delta – V Distributed Control Systems (DCS) , Laboratory Information Management systems (LIMS) and Manufacturing execution systems (MES) validation activities such as functional and development test generation and execution• Initiated and drafted user requirements (URS) and detail design specifications (DDS) using UML use case diagrams and pseudo codes.• Engineered additional validation deliverables such as Standard Operating Procedures (SOPs), Detail Design Specifications (DDS), Functional Requirements Specifications (FRS), User Acceptance Tests (UAT), risk assessments and traceability matrices for a wide range of systems.• Conducted and lead risk assessment meetings and analyzed the severity, probability of occurrence and likelihood of detection for system related hazards using Preliminary Hazard Analysis(pHA's).

• Worked as a consultant for clients such as Centocor, JNJ and Discovery Labs.• Conducted evaluations with system owners to gather information and requirements specification for laboratory equipments used for supporting pilot plant operations and computer systems.• Developed and executed all validation deliverables such as validation plan, Installation Qualification(IQ), Operational Qualification (OQ), traceability matrices, system specific test scripts and their reports.• Performed document review cycles with Centocor Quality & Compliance to address any regulatory concerns.• Gathered system requirements to develop URS, FRS and design documents.• Lead a project that involved generation of IQ and OQ test scripts for LIMS systems.• Delivered presentations on program functionality for users and groups that created training modules. • Certified in client bases Validation training courses such as 21CFR Part11 and GMP, GLP and GCP training.• Updated Functional specifications, IQ and OQ for an upgraded version of the SCADA (Supervisory control and data acquisition) software.• Developed necessary documentation to ensure that the SCADA system is in compliance with FDA guidelines.