Our team has considerable experience working with clients of all sizes to design bespoke strategies to deliver global registrations efficiently and cost effectively. We can also use our comprehensive knowledge of the global regulatory environment to develop and implement creative and innovative strategies designed to maximise the long-term success of clients’ products.
Product Registration & Maintenance
We have numerous experienced consultants who have dealt with all aspects of the due diligence process; in working on projects at Acorn Regulatory and previous industry experience in large pharmaceutical companies. Including applications to European procedures from MRP, DCP, CAP through to DMF’s and CEP applications.
Our publishing team can help you build your submission package in eCTD (or NeeS) and submit it to the national competent authorities (NCA) via CESP or the national portals as appropriate for Europe and to the FDA via the Electronic Submission Gateway (ESG). Our flexible and competent team can turn your dossier to a submission-ready file faster than our competitors. Our EDMS provides comprehensive lifecycle management and can handle every sequence you prepare. We QC each application before releasing to assure success. To ensure completeness, we perform a post-publishing QC assessment. We meet local submission standards with our European partners.
“I have worked with Acorn Regulatory on many OTC campaigns and at this stage have been more than impressed with the insight and overview that they brought to each of the campaigns we worked on. At times debate has been lively but always working towards the end point to enable work to get done” Regulatory Affairs Manager for a Top 10 Pharmaceutical company headquartered in the USA.