Business Case: Global Project Management in Regulatory Affairs


KVALITO supports Life Science companies in leading global cross-functional mergers and acquisitions, GMP, Regulatory and Clinical programs and operations in various project stages, including Drug Discovery, Preclinical, Clinical, Manufacturing and Marketing.  

KVALITO has expertise in managing Regulatory Affairs Projects and delivery of Quality and Compliance GxP projects worldwide. Business excellence is assured through the harmonisation and implementation of digital solutions to provide continuous improvement and design thinking methodologies worldwide in a cost-effective and quality manner. 



  • One of the challenges is gaining a complete understanding of stakeholder requirements from a quality and regulatory perspective. This can be carefully managed by ensuring that the projects are clearly scoped at the initial planning stages and throughout the project lifecycle to ensure effective and timely delivery of the key deliverables. 
  • It can be challenging to navigate and account for different country-specific stipulations for submissions that may be quite different, for example, the United States and Europe. Global regulations must be monitored for changes or differences that may impact submission requirements in a context of constant developmentmergers and acquisition 
  • Another challenge is ensuring that companies are kept informed about key trends related to operational excellence and continuous improvement initiatives in the pharmaceutical and medical device sectors. Benchmarking and having access to access to a network of special interest groups (e.g. ISPE, PDA, Bioforum etc.) and Life science influencers provide the supporting mechanism to keep up to date with the changing environment.  
  • It is important to strike a balance between ‘perfection’ and being sufficient so that regulatory commitments are addressed in a timely manner whilst ensuring that the content is accurate and compliant. 


What KVALITO did

Project Management 

KVALITO managed and supported ‘end to end’ Global Project Management through all regulatory phases including Drug Discovery, Preclinical, Clinical, GMP Production and Marketing by defining and planning activities with key stakeholders, including Project Goals, Business Cases and Project Charter creation. 

  • Customer-focused: Identification and analysis of customer requirements and the allocation of the adequate budget and resources and SLA, RFP, MSA and contracts following client’s requirements and policies.  
  • Stakeholder Management: Coordinated activities with multiple stakeholders: Regulatory, IT systems, Digital, Medical Affairs, Quality, and Procurement.  
  • Collaboration: Negotiated GMP Lab Services and projects with our large pharma clients and internal/ external stakeholders (Including scope definition, resources, tools and budget for the implementation and roll-out of GMP Lab Services)  
  • Monitored and improved contracts with global suppliers. Implemented ‘Win-Win’ solution across the o organisation   


KVALITO supported the definition and execution of Project Plans; by driving the activities across Global Drug Development in compliance with cGMP (FDA, ICH & EU GMP) GLP, GCP, ASTM, Health Safety and Environment (HSE) and GMP Advanced Therapy Medicinal Products (ATMPs) for multiple products:  

  • Led clinical supply project enhancements and clinical service operations for IRT (Interactive Response Technology) to ensure the randomisation and release of IMPs (Investigational Medical Products) between Global Technical Research Development Unit sites and transportation depots in compliance with ICH-GCP E6.  
  • Led Merge and Acquisitions projects to integrate MAPs (Managed Access Programs) and IITs (Investigator-Initiated Trials) processes from our large pharma client Gene Therapies unit to our global client organisation. This involved a streamlined process for the request, review and approval activities throughout the project lifecycle, including submission and patient safety reporting in compliance with Global and Local Medical Affairs regulations.   
  • Defined the project goals, redsources management, harmonisation of the validation strategy between different entities.  
  • Successfully completed the GxP Data migration execution between different entities in compliance with 21 CFR Part 11 for Quality Management, Inspection and Audit Management systems such as Track Wise. 
  • Lead Digital Global Validation of GxP systems across multiple Global Technical Research Development sites, which involved equipment and facilities qualification, labelling and clinical software validation (Computer System Validation) following GLP and cGMP regulations. 
  • Furthermore, KVALITO has Clinical Expertise (GCP-ICH E6), cGMP expertise (FDA, EMEA and ICHs), Medical devices expertise, i.e. Medical Devices including IVDs, SaMD and Quality Management Systems, ISO 13485, Pharmaceuticals, Biologics and Biotech products and Cell & Gene Therapies (Quality, Safety and GMP Advanced Therapy Medicinal Products (ATMP) Certificate by European Compliance Academy)  
  • Management and implementation of Development IT Digital Solutions.  
  • Data Migration in regulated environments.   


People, Processes and Tools 

People / Roles: 

  • Project Management  
  • Regulatory Affairs  
  • Business Analyst  
  • Project Quality Manager  
  • Quality Manager  
  • IT Lab Manager  
  • IT Project Manager 
  • IT Quality and Test Manager  
  • Testing and Integration Team  
  • Biochemist – Specialty in Human Genetics and Molecular Diagnostics.  


Tools and Technologies

  • Office 365 
  • MS Project Management 
  • Planview  
  • Integration Hub  
  • Submission Software Subway 
  • Safety Reporting tools with Health Authorities  
  • CyberGrants 
  • SAP  
  • JIRA 
  • Trackwise 
  • Pilgrim SmartSolve 
  • MasterControl 
  • Veeva 
  • Oracle 
  • C3i 



  • Full Life Cycle Project Management following PMP, Agile PM, Scrum 
  • Strategic Planning and Analysis 
  • Quality & Performance Optimisation 
  • Regulatory submission process  
  • GxP and Regulatory Processes (Good Clinical Practice, Safety and GMP Advanced Therapy Medicinal Products (ATMP))  
  • Procurement and Record Management 
  • Staff Training and Development 
  • Team and Time Management 
  • Issue Identification and Resolution 
  • Medical Devices Regulatory Compliance: IVD, IVDR, MDD/MDR and SaMD


Value Delivered 

Delivered Projects using Best in class Project Management skills: MBA/ Project Management Professional (PMP®), Scrum, Agile PM. 

  • Enabled Agile and Design thinking supporting team leader focus to identify and resolve customer and team requirements and cross-functional challenges.  
  • Performed GAP Assessments and identified process gaps and improvements and new technologies to streamline operations in quality in a timely manner. 
  • Reduced operating expenses by identifying the appropriate suppliers and new technologies to streamline operations in a quality and timely manner. 
  • Subject Matter expertise in cross-functional areas of biotechnology, chemistry, and pharmaceutical environment in compliance with cGMP guidelines for Global Drug Development projects  
  • Met target goals in ensuring that all Digital Solutions to comply with regulatory requirements whilst meeting performance milestones. 


Clients / References

  • Novartis 
  • AveXis 




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