Reducing costs by embedding quality into every phase of development
- Continuous manufacturing transitions with QbD, tech insight, and cost-optimization
- Plan - operate - adapt as needs evolve.
Welcome
The Market Entry
Bringing a drug product into the market demands a profound understanding of regulatory standards, quality assurance, and comprehensive product and process development. Our approach, grounded in Quality by Design (QbD) principles, ensures that quality is built into every stage of the process. Together with your team, we will develop a strategy, and work with regulatory agencies to ensure a smooth approval process. We will also lay the scientific groundwork for post-approval commitments, significantly saving the client's overall program time and money.
Advanced Manufacturing/PCM
We help assess the benefits of transitioning to a continuous manufacturing platform and provide strategic support, including business case analysis, development, equipment selection, and regulatory compliance. Our experts, familiar with the latest equipment and technology, ensure a seamless transition to pharmaceutical continuous manufacturing. By incorporating QbDmethodologies, we guarantee that quality is an integral part of every step.
Our customized solutions in these focus areas are in addition to long-established expertise in optimizing the true cost of ownership, from construction to full operation. Our services, designed with QbD principles, adapt as regulatory, scientific, or business conditions change, ensuring a resilient and high-quality route-to-market.
We do
•Leverage our diverse, multidisciplinary team of technical experts, covering all domains from project management to regulatory compliance, and from APIs to cell and gene therapies, with a strong emphasis on QbD principles.
•Solve complex problems definitively, ensuring your success on the first attempt through a quality-centric approach.
•Operate with a hands-on approach, including site visits and other tailored steps, to develop customized solutions that prioritize quality for your unique situation.
Quality by Design - every step of Pharmaceutical Development
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