Regulatory Maintenance 2017-11-06T16:13:09+00:00

Regulatory Maintenance

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.

  • IDMP/ XEVMPD.

Our Regulatory pre-approval services:
  • CTAs, IMPDs, INDs, NDAs, MAA, global registration submissions.

  • DMFs.

  • 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.

  • In-country support.

  • Regulatory intelligence.

  • 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.

Source local regulatory experts with k-net

k-net is our network of Life Sciences experts, comprising of over 1,200 individual experts spanning 160 countries.

Using k-net, we can source local experts who can provide regulatory intelligence for any market, support local submissions and engage with local regulatory authorities on behalf of clients.

Learn more about k-net

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Get in touch with our expert team

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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.
View all of our services and see how they fit into the drug development life cycle.

Regulatory Strategy 

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.

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Quality and Compliance

Our four stage robust quality and compliance approach helps drive and embed a quality culture across our clients organisation.

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