Quality Control/Analytics
Product Quality & Compliance ExcellenceCommitment to Deliver Product Quality
Dynamic Engineering Solutions provides comprehensive analytical and quality control support across all stages of drug development. From method development to routine testing and regulatory compliance, we ensure your products meet rigorous standards for safety, efficacy, and quality.
Guiding analytical strategy through dataAnalytical Development (AD)
Analytical Development provides scientific expertise to support key decision points related to product safety and efficacy across all phases of development.
We establish a comprehensive understanding of your product’s structure in alignment with its mechanism of action and regulatory expectations, applying strategic approaches to develop robust analytical tools for process materials assessment.
High Structure, High ROIOur AD Framework
We build a structured framework to uphold the core principles of AD, including:
Developing accurate, fit-for-purpose analytical methods to measure critical quality attributes (CQAs) such as identity, safety, and efficacy.
Defining the Analytical Target Profile (ATP) to support the Target Product Profile (TPP).
Leveraging characterization data to enhance product knowledge and optimize methods with innovative technologies.
Driving Data-Backed DecisionsOur QC Framework
Quality Control ensures products are consistently safe, effective, and high-quality by establishing a clear product testing system that aligns with global regulations.
This involves setting specific, science-based goals for the product’s most critical features and using a risk-based approach to confirm testing methods are reliable across all phases. Use of continuous monitoring and improvement processes to ensure trustworthy data is generated to meet regulatory approvals.
Ensuring compliance of test panels for product release, routine testing, and stability studies across the product lifecycle.
Monitoring analytical method performance to maintain consistent product quality, patient safety, and efficacy.
Meeting regulatory requirements for data integrity and ICH Q14 standards.
Connect With Our Team TodayAdvance Your Drug Program
with Confidence
Start building reliable, high-quality drug development programs today.