About ProClinical Consulting
At ProClinical Consulting we partner with life science companies to provide tailored end-to-end Quality, Compliance and Regulatory solutions, delivered by our unrivalled global network of industry-leading professionals.
With our blend of deep industry expertise and flexible approach, we function as an extension of your team, to achieve a successful outcome.
Our strong relationships with regulatory bodies and saleable solutions, locally and globally, ensure we deliver to your needs and optimise your productivity and success.
Our deep understanding of the global regulatory landscape and far-reaching network ensure we deliver best-in-class regulatory strategy and management solutions.
Consent Decree Remediation Project
A leading global medical device company received a Consent Decree and had a critical site in Germany put into remediation. An urgent, expert response was required to get the site back into action.Read more
Life Cycle Management For Registered Products
A top 40 biopharma company was seeking a regulatory outsourcing partner with expertise and global reach to manage and perform regulatory affairs and operations activities in support of legacy marketed products – 700+ active licenses, 20+ countries.Read more
M&A Regulatory Support
An EU-based large pharmaceutical company was facing a large regulatory burden due to M&A activities after acquiring a diverse portfolio of established products and needed global / local affiliate support for the transfer of licenses.Read more
Outsourcing of Technical Writing Activities for Externally Produced Products
A large pharmaceutical company were looking for CMC and labelling support to support a CMO consolidation exercise globally.Read more
Quality & Validation Remediation Project
Our client, a leading global pharmaceutical company, had several key sterile manufacturing sites put into remediation following an FDA warning letter.Read more
Sterile Remediation Project
Our client, a leading global pharmaceutical company, had a key sterile manufacturing site put into remediation following an FDA warning letter. We met with the leadership team at the site in Italy to discuss exactly what Regulatory Compliance solution they needed.Read more
MDR Transformational Program
Our client, a globally recognized medical device business, reached out to us for help with becoming MDR/IVDR compliant by 2020 after release of the new regulations. This is a significant piece of reform that required immediate action across their entire European Operations.Read more