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.
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.
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”.
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.
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.
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.