Regulatory eSubmissions in VNeeS, NeeS and eCTD Format

A-consult can help you prepare Regulatory eSubmissions in VNeeS, NeeS and eCTD format. Technical know-how in Regulatory Affairs Departments has increased following the requirement for Regulatory Submissions in Electronic Format.The switch in regulatory submissions from manual print/copy work to specialised technical work can cause submissions to be delayed. Managing the varying workload levels of required Regulatory eSubmissions can be difficult, even for larger companies with dedicated eSubmission teams. Once fully implemented, the requirement for eCTD submission will mean all pharmaceutical companies will have to invest in and maintain expensive publishing tools or to consider outsourcing of the publishing task.

A-consult’s dedicated team of experienced pharmaceutical consultants can assist with specific projects e.g. classification of variations, preparation of application forms or writing of specific regulatory documents, prepare the entire submission or manage the complete outsourcing of your eSubmissions. A-consult’s consultants’ pharmaceutical and technical knowledge means, they are able to assist in the preparation of the Regulatory eSubmissions content, ensure that prepared documents are eSubmission-ready and finalise the VNeeS/NeeS/eCTD.

A-consult’s aim is to deliver on time, high-quality, compliant Regulatory eSubmissions.

A-consult offers:
• Advice concerning regulatory eSubmissions in VNeeS, NeeS and eCTD format
• Technical validation of your dossier/documents to ensure compliance with current validation criteria
• Preparation and submission of marketing authorisation applications, variations, renewals etc. in VNeeS, NeeS or eCTD format

For more information or to discuss regulatory eSubmissions in VNeeS, NeeS and eCTD format please contact us directly.