Washington DC, US headquartered Swiftwater will help Patheon’s clients navigate the increasingly choppy regulatory seas, providing advice on drug development, documentation and product submission.
Patheon CEO Wes Wheeler said the partnership provides a useful expansion of the firm’s portfolio, explaining that: “Many of our clients benefit from strategic and tactical assistance with their NDA filings, 505(b) 2 filings, bioequivalence requirements, technical transfers and paediatric line extension strategies.”
Thomas Fritz, Managing Partner of Swiftwater added that the partnership will cover “the full development spectrum from pre-clinical to regulatory approval, at the same time ensuring tight coordination of manufacture, nonclinical program development and execution, clinical study design and execution, and regulatory documentation."