Marketing Authorizations (BLA/MAAs)
BioVentures Consulting Limited has the expertise and experience to project manage our clients marketing authorizations from concept through to submission and approval
BioVentures Consulting Limited has the expertise and experience to project manage our clients marketing authorizations from concept through to submission and approval. These include both Biologics License Applications (BLAs) and Marketing Authorization Applications (MAAs) or New Drug Applications (NDAs). BioVentures Consulting Limited has the capability to publish the submissions in Common Technical Document format eCTD in accordance with the CHMP / ICH guidelines with a common presentation for the EU, Japan and the USA.
We can take on project management or project leadership across any or all Modules, including all the administrative information and prescribing information for Module 1 (Application form and SmPC, labelling and leaflets); the Module 2 summary documents; and Module 3 (Quality), Module 4 (Nonclinical) and Module 5 (Clinical).
The format of the CTD is designed to accommodate electronic submissions which accommodate the Modular structure using a simple numbering system and logical hierarchy of information. In this regard BioVentures Consulting Ltd offers regulatory publishing services in eCTD format using our own hardware and licensed software (see Regulatory Operations and Publishing Services).