Get the support you need for an optimal journey from lab to market.
Benefits this Solution Provides
Develop a Robust CMC Strategy
Count on 18+ years of extensive pharmaceutical consulting experience.
Get services tailored to meet your changing needs at any stage of the drug development process.
Fully align with guidelines developed by the FDA, EMA, and other health authorities.
Form Strategic Partnerships
Identify the most appropriate service providers (CDMOs, contract laboratories, and more) to help you bring your life-changing products to market sooner.
Understanding Your Product
- Our approach prioritizes a scientific understanding of your product and process, which we combine with our extensive knowledge of regulatory expectations and requirements to create a robust CMC strategy.
- Get support on process and formulation development, analytical development identifying critical quality attributes (CQA) and critical process parameters (CPP), developing control strategies, establishing quality testing methods, and validation activities.
Satisfy Regulatory Considerations
- Establish standards that demonstrate consistency, safety, quality, and stability between the product used for clinical trials and the one produced for commercial distribution.
- Properly analyze and provide evidence of the manufacturing processes, drug substance and/or drug product characteristics, and testing to ensure product safety and efficacy.
Speed Up the Process
- Accelerate this process by selecting the appropriate partners during all phases of product development.
- Get support on your manufacturing planning and oversight of technology transfers, process scale-up, batch manufacturing, comparability studies, process optimization, and more.
|Process is likely to take longer which means having a later return on investment.||Benefit from our expertise of global regulatory and quality experience to accelerate time-to-market.|
|Increased risk of non-compliance with regulatory requirements.||Stay compliant by fully understanding the regulatory landscape and updating your strategy accordingly.|
|Tackle the challenges of the laboratory to market journey with fewer resources.||Have the support of an experienced team on your specific needs throughout the process.|
|Before||Process is likely to take longer which means having a later return on investment.|
|After||Benefit from our expertise of global regulatory and quality experience to accelerate time-to-market.|
|Before||Increased risk of non-compliance with regulatory requirements.|
|After||Stay compliant by fully understanding the regulatory landscape and updating your strategy accordingly.|
|Before||Tackle the challenges of the laboratory to market journey with fewer resources.|
|After||Have the support of an experienced team on your specific needs throughout the process.|
See how ValGenesis can support your digital transformation.