Regulation & Quality

Thanks to decades of experience in the pharmaceutical industry, Dow Pharma Solutions has a demonstrated track record in working with customers to successfully develop and formulate approved systems. Our product stewardship, manufacturing excellence and quality and regulatory specialists across the globe work closely with internal and external stakeholders to address customer challenges.

Manufacturing excellence

Dow Pharma Solutions has a large manufacturing network, robust business continuity plans for all chemistries and the global logistics capability to provide drug manufacturers with a consistent and secured supply worldwide. We also have commercial scale-up capabilities and a cGMP market development plant capable of supporting the clinical development of optimized solutions. All our locations must meet the standards of excellence for manufacturing, quality control, environmental stewardship and safety set by The Dow Chemical Company regardless of their location. We use a rigorous auditing process to ensure that our locations meet these standards.

Quality by Design (QbD)

Employing Quality by Design (QbD) in the development of drugs mitigates risks. By understanding all critical aspects of drug development and control strategies, QbD investments in the product and process development can bring significant benefits. These include cost savings, improved process and product robustness and regulatory flexibility (QbD filing), which allows for continuous drug improvement without prior regulatory approval (in most countries).

With our extensive knowledge and experience in manufacturing HPMC, EC, PEO, CMC and MC, we are a great polymer partner for QbD initiatives. Our experts have a deep understanding of the structure and property fundamentals that are critical to the successful use of cellulosic polymers in active pharmaceutical ingredients (APIs). We employ highly sophisticated methods for analyzing chemical structures and rheology to develop more robust drug formulations. We also help you reduce development risks by providing customer support from the proof-of-concept stage to the commercial drug launch.

Regulatory Expertise and Activities

Our network of experts in product safety, toxicology and pharmaceutical regulations have a deep market segment and regional understanding of the pharmaceutical regulatory environment. The team supports business growth by assessing the safety of new product launches and obtaining the license-to-sell in compliance with stringent pharmaceutical and medical legislation globally. Our regulatory support and impact would not be possible without our extensive participation and leadership in key industry associations, such as ‘The International Pharmaceutical Excipients Council’ (IPECs Europe, Americas, Japan and China) where we play a key role in issue management and advocacy in emerging and changing legislation.