Business Process Management

PRODUCTS

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    CGT Expert Consulting Team

    At ProPharma, our Cell and Gene Therapy consulting team offers a comprehensive and integrated approach to early-stage cell and gene therapy development. Our expert team provides a range of services, including IND/CTA preparation, manufacturing technology, safety and risk assessment, and development planning, to help our clients navigate the complex and ever-changing landscape of cell and gene therapy development.

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    FDA 21 CFR Part 11-Compliant Software

    Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?

    Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.

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    Program & Project Management

    While there are industry standards for program and project management, each company has a unique culture and is at a different point in their product development journey. Verista's experienced team works with you to effectively manage and control your project, programs and portfolios.

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    Process Development

    In cell and gene therapies, the process is the product. We have deep expertise developing and scaling processes for cell therapies and viral vectors, including lentiviral vectors and AAV.

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    Achieve Efficient Viral Vector Production At Any Phase

    The Challenge: Building Scalable Viral Vector Programs

    Cell and gene therapies offer unprecedented hope for previously untreatable diseases. At the heart of many of these advanced therapies, including both gene therapies and gene-modified cell therapies, are viral vectors, particularly Adeno-Associated Vectors (AAV) and Lentiviral Vectors (LVV), which serve as crucial gene-delivery vehicles.

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