Recro Pharma Inc., a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, announced that it has expanded the clinical capabilities of the company’s growing Clinical Trial Services (CTS) offerings. Included among the newly added CTS capabilities are clinical-scale sachet and blister packaging for clinical trial pharmaceuticals.
Additionally, Recro has established a relationship with a European Union Qualified Person (QP) for its CTS offerings following a successful review process. This QP has audited the company’s facility and stated that Recro meets the relevant GMP manufacturing standards and requirements for clinical trial materials to be used in the EU. Based on this audit, the QP organization has agreed that it can represent Recro’s clients for the release of materials in the EU. A QP declaration is required for any biotechnology or pharmaceutical company seeking to conduct a clinical trial in Europe using a drug product manufactured in a non-EU country, allowing Recro to support the Europe-based clinical trial efforts of its customers.
“While our addition of CTS offerings is not yet a year old, it has already provided opportunities for our existing clients to expand their scope of work with Recro, as well as serving as a gateway for attracting new customers. This is highlighted by the fact that our recent expansion of packaging services has played an important role in increased client interest and attracting new business,” stated Scott Rizzo, senior vice president and general manager of Recro.
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