Consulting Services
Quality Compliance
Our strong relationships with regulatory bodies and saleable solutions, locally and globally, ensure we deliver to your needs and optimise your productivity and success.
Regulatory Affairs
Our deep understanding of the global regulatory landscape and far-reaching network ensure we deliver best-in-class regulatory strategy and management solutions.
Case Studies
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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