Regulatory
As you review and strengthen GMP compliance in worldwide markets, we can help with specific projects such as bringing regulatory filings and submissions up to standard.
There's little we don't know about evolving regulatory requirements
Our deeply-experienced Regulatory experts can provide help right across the regulatory lifecycle, to ensure that dossiers are up to scratch pre-, during, and post-submission.
How we can help
From initial dossier review and gap analysis, to hands-on help with eCTD submissions, to longer-term variation management, we’ll help you accelerate market delivery and maintain ongoing compliance.
We can provide these services for both drug substances and for finished drug products.
Pre-submission review
We’ll review your dossier and provide a detailed gap analysis so that you can ensure your submissions are successful first time.
Submission support
Our experts can help you fill any gaps, draft content as needed, and submit the finished dossier to the relevant agencies in the correct eCTD format.
Post-submission lifecycle management
We’ll help you maintain compliance on an ongoing basis, ensuring robust variations management and continuous tracking of evolving authority requirements.
Let's make contact
Rephine
15 Meadway Court
Rutherford Close
Stevenage
Hertfordshire SG1 2EF
United Kingdom
