OPG, provides extensive regulatory services to meet the customer’s needs
In addition to contract manufacturing, Orofino Pharmaceuticals Group can offer a range of qualified services particularly in the quality, technical and regulatory areas.
Orofino Pharmaceuticals Group has a major commitment to high quality in all aspects of its operations:
Product transfers and validation
Plant operations and product manufacturing
Product testing and release
Regulatory compliance at all stages of the process
Recently, a significant focus has been on sterile containment production. Investments in barrier technology and containment practices on sterile filling lines has ensured our standards are aligned with evolving regulations. Orofino Pharmaceuticals Group can provide full regulatory and technical support for the transfer and validation of products in all of its plants. It has considerable experience with successfully delivering complex transfers, having successfully completed the transfer of 155 SKU’s for supply to 74 markets from an external site into one of its plants. The technical expertise across the Orofino Pharmaceuticals Group is available for the development and improvement of formulations and processes as part of any transfer process. The Regulatory Department in Orofino Pharmaceuticals Group has extensive experience in dealing with regulatory transfers and is able to assist in the regulatory process of managing dossier updates and transfer submissions.