RECRO Expands Capabilities for Clinical Trial Services

Recro Pharma, Inc., a CDMO dedicated to solving complex formulation and manufacturing challenges for oral solid dose drug products, has expanded clinical capabilities for its growing Clinical Trial Services offerings to include 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 release of materials in the EU. 

A QP declaration is required for any pharma/biopharma company looking to conduct a clinical trial in Europe using a drug product manufactured in a non-EU country, allowing Recro to support its clients Europe-based clinical trial efforts.

“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,” said Scott Rizzo, senior vice president and general manager of Recro.  “In addition to the growing traction of the CTS offerings in the U.S., we are now positioned to carry momentum into the European market based on the successful QP audit.”