Patheon has entered an alliance with Swiftwater Group, LLC to provide regulatory consulting services to clients. According to a Patheon statement, Swiftwater Group can assist Patheon clients "as they navigate through the regulatory process, by providing expertise in regulatory strategy for CMC, non-clinical, and clinical development and by assisting clients to prepare and manage their regulatory submissions."
Wes Wheeler, Patheon's chief executive officer and president, remarked, "This new partnership allows Patheon to further expand its services portfolio. We have found that many of our clients benefit from strategic and tactical assistance with their NDA filings, 505(b) 2 filings, bioequivalence requirements, technical transfers and pediatric line extension strategies. We can now offer a complete service to our clients."
Thomas Fritz, managing partner of Swiftwater Group, stated, "With the combined Resources of our two companies, we are uniquely positioned to offer Integrated Drug Development services that span the full development spectrum from preclinical to regulatory approval, at the same time ensuring tight coordination of product manufacture, nonclinical program development and execution, clinical study design and execution, and regulatory documentation."