Preclinical / Nonclinical
Preclinical (nonclinical) development refers to the process through which investigational drugs are subjected to extensive laboratory testing to determine their safety for humans.
Biopharmaceuticals
Marketing / Biologic Licence Authorisation Applications
Introduction
Making Biologic Licence Authorisation (BLA) preparations simple
Moving from the clinical development stage to preparing for Biologic Licence Authorisation (BLA) / 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, if you wish to do so, the entire BLA / MAA application may be prepared and submitted by Woodley BioReg — all of our licence applications have received regulatory approval.
Collating and preparing m2, m3, m4 and m5 sections of your dossier
As well as reviewing all the technical information and data from the preclinical, clinical, and manufacturing development stage, we can also prepare all sections for the biologics license application and Common Technical Document (CTD) — ensuring both compliance and conformance.
Because all of our consultants are ex-industry and regulators with biopharma experience, writing and reviewing complex 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.
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,
Regulatory
strategy
As data is generated, it’s not unusual for the regulatory strategy to continue to evolve to ensure compliance and conformance, we provide our clients with strategic advice on pre-submission and post-approval optimisation activities as part of our ongoing commitment.
