We have an unmatched global Pharmaceutical Regulatory Maintenance and operations capability to deliver exclusive end-to-end solutions for the life cycle maintenance of your product portfolio.
The one stop solution for Regulatory Operations
Our expert Regulatory Operations team are well equipped with exclusive and state-of-the-art technology. We’re capable of tracking, executing and managing the regulatory operations activities of all submission types for our clients.
We help our clients with:
Document Publishing, including all submission types and formats.
Submission Publishing, including paper, NeeS and eCTD publishing.
Submission Dispatch Management including electronic gateways, CDs and Prints.
Product dossier and document management.
Regulatory Information Management (RIM)- strategy development, process and systems diagnostics, system configuration and associated business process alignment.
Labelling operational support.
Our Regulatory pre-approval services:
CTAs, IMPDs, INDs, NDAs, MAA, global registration submissions.
EDQM Certificate of Suitability applications.
Territory-specific site registration applications.
Our Regulatory post-approval services:
End-to-end life cycle management service supporting licence maintenance (variations, renewals, annual reports, PBRER/ PSURs).
Safety, manufacturing and CMC activities through to regulatory services.
Linguistic Review including labelling and artworks.
Site rationalisation regulatory support.
Compliance gap analysis.
Stability data assessments.
CTD conversions (content and format).
Regulatory Maintenance and operations in every Pharmaceutical market
We have a network of local affiliates and agents, who can provide local submission support and case management in any Pharmaceutical market. We have worked closely with these experts over many years – they allow our clients to flexibly approach any market and confidently comply with regulations.
Explore more of our services
Our Regulatory services are a real ‘power house’ within our portfolio. Working on a global scale we support the majority of the world’s pharmaceutical companies helping them anticipate regulatory change and optimize their end-to-end regulatory activities.
Our Regulatory Strategy team work with your in-house team to develop comprehensive regulatory strategies, which allow your organisation to successfully commercialize your products, unhindered by regulatory slow-downs.