Pharmaceutical

Marketing Authorisation Applications

Introduction

Making Marketing Authorisation preparations simple

Moving from the clinical development stage to preparing for Marketing Authorisation (MA) can seem daunting, but with structured and tailored support from our regulatory consultants at Woodley BioReg, the process can be painless.

Using our vast knowledge and practical experience of the process with a range of boards of health across the globe, we can facilitate a smooth preparation process with the assurance of application approval.

You can be assured in the knowledge that all of the licence applications made by Woodley BioReg have received regulatory approval.

Collating and preparing m2, m3, m4 and m5 sections of your dossier

As well as reviewing all the information and data from the preclinical, clinical, and manufacturing development stage, we can also prepare all sections for the license application and Common Technical Document (CTD) — ensuring both compliance and conformance. Because all our consultants are ex-industry and regulators, writing technical documents is our forte, so you can rest assured that we will “tick every box”.

For more information about the sections of the dossier, visit our resource centre.

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Review of client’s
in-house drafted MA

If you have already drafted your CTD, we’re always at hand to provide a comprehensive review to ensure minimal RFIs and review clock-stop periods, and a rapid regulatory approval.

NtA to CTD
conversion

Notice to Applicants (NtA) dossiers preceded the CTD, and while many companies have already converted their NtA dossiers into the new format, we still see a number of files in the old format that are overdue conversions for ongoing compliance.

With our extensive experience, we’ve developed highly accurate and automated systems to minimise human / transcription errors and generate CTD structured dossiers for regulatory updates; we call this our “makeover” process.

For more information about the NtA to CTD conversions,

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Regulatory
strategy

As the regulatory strategy continues to evolve and is updated to ensure compliance and conformance, we continue to provide our clients with strategic advice on pre-submission and post-approval optimisation activities as part of our ongoing commitment.

Preparing your Marketing Authorisation (MA) application doesn’t have to be arduous — our team of professionals are on hand to offer advice and guidance to ensure licence applications are always approved.

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