GxP Consulting Services
ValGenesis Consulting combines industry experience and process mastery to help you transform your business to deliver life-saving products to market with higher speed, quality, and confidence.
Meet Challenges. Unlock Opportunities.
In the life sciences, change is constant. Agility and continuous improvement are what separate good companies from great ones. Achieving operational excellence in the face of regulatory challenges and lengthy development cycles is difficult for any team.
The experts of ValGenesis Consulting understand the unique challenges of your industry. Every day, around the world, our discerned insights shape the strategies that enable life sciences companies — from premarket start-ups to multisite global corporations — to bring discipline to operations, clarity to processes, and foresight to technology investments. The result? Solving today’s problems while rising toward tomorrow’s possibilities.
From Concept to Commercialization
Our consulting services impact all phases of the product and process lifecycle, from R&D through commercial operations.
And because they’re process-based, any regulated organization, regardless of the enterprise systems they use, can benefit from our multidisciplinary approach.
We offer guidance in three core focus areas:
Efficient processes empower you to function at a higher level. Leverage our data-driven insights to optimize resource usages, improve operations, enhance decision-making, and drive real results while containing the costs of compliance.
- Early-phase drug screening with machine learning
- Quality by Design (QbD)/retrospective QbD implementation support
- Scale-up and technology transfer
- Data science-driven process design, optimization, and understanding
- Process troubleshooting
- Process simulation with digital twins
Every product or process has associated risks. We partner with you to identify, qualify, and prioritize risks so that you can build risk mitigation strategies throughout the lifecycle of your products, equipment, facilities, suppliers, analytical methods, and other assets and activities. We’ll help you advance your existing QRM practices by leveraging the power of your data to enhance decision-making and anticipate and respond to risk more effectively.
- Strategic QRM maturity programs
- ICH Q9 (R1) compliance assessment services
- Data-driven risk management programs
- Risk management facilitation
- Risk management training
Navigate the path from product concept to market delivery with confidence. We’ll help you build a comprehensive CMC strategy that can withstand regulatory scrutiny and ensure the quality, safety, efficacy, and consistency of your products and processes.
- Lab-to-market acceleration
- Strategic validation and continuous process verification programs
Bring your vision to life sooner with GxP Jumpstart Packages
Reach your business and development goals faster with our predefined consulting offerings. Each GxP Jumpstart Package includes assessments, plan development, access to proprietary technology, and structured project management.
Our team of engineers, scientists, strategists, and problem solvers will work alongside your team to implement a standardized process methodology that is compliant, efficient, and scalable, then show you how to replicate that proven methodology seamlessly throughout your broader product or system portfolio.
GxP Jumpstart Packages are based on current regulatory guidelines and industry best practices. Their outcomes are designed to accelerate innovation, drive efficiency, optimize manufacturing, and shorten time to market.
GxP Jumpstarts are an ideal introduction to our services and can be customized to meet project complexity and client needs.
Our Experts Are the Best at What They Do.
Our team of industry experts possesses a thorough understanding of global regulations and the trends shaping the future of life sciences businesses. This knowledge, coupled with unmatched technical expertise, will help you refine your operational processes and go-to-market strategies to accelerate growth. Consultants bring 10+ years of international real-world expertise to your project.
Our consultants are recognized as top subject matter experts in their fields and are frequently invited to share their thought leadership at industry conferences and events.
Through our blogs and technical papers, they address what’s trending in the life sciences and share actionable advice and practical tips for traversing today’s evolving regulatory landscape.
We help life sciences companies around the world make sense of global compliance and find new ways to streamline, modernize, and digitize their business processes.