Biologics Licence Application authorisation submissions


Preparing Biological Products Marketing Authorisation Applications for submission

At Woodley BioReg, we provide comprehensive publishing and portal submission services including Non-eCTD electronic submissions (NeeS) and electronic Common Technical Document (eCTD). Our team of Regulatory operations experts are well-versed in the composition and requirements of these files, and use the latest eValidator tools prior to submission so you can be confident that it will not be rejected.


The final compilation of regulatory documents can seem IT-heavy and intimidating, but with our qualified team on hand to support you in eCTD publishing – from assignment of documents within the eCTD modular structure to submission validation — you can be sure you’re in competent hands.

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With most regulatory authorities requiring submission of licence application and variations through dedicated portals, Woodley BioReg is registered on all of the major EU, UK and US portals to expedite our client’s submissions and removing another hurdle to successful applications.

RFI responses

Given the increased complexity of some products and manufacturing processes, it’s not unusual for regulatory reviewers to request clarification or additional information during the review of a licence application. As part of our regulatory strategy, we’ll work with you to ensure all potential areas for information request as mitigated, and where this is not possible, remediation actions are agreed to ensure data / information availability during the review process to minimise regulatory clock-stop periods.


At the BLA submission stage, regulatory strategy is more vital than ever.
Our team of specialist regulatory consultants have a high level of understanding of all aspects of UK/GB, EU, and US registration pathways, enabling us to ensure ongoing compliance, avoid unnecessary delays, and mitigate any risk of refusal to file (RTF) or rolling RFIs.

Publishing and submitting NeeS or eCTD documents can be laborious and incredibly time-consuming, requiring a high level of attention to detail that can be very resource draining. That’s why our clients rely on Woodley BioReg’s regulatory consultants to support them through this stage of product registration.

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