Consulting

Medwisdom can provide useful regulatory affairs advice at all stages of product development, from the early concept stage, through product development, up to and beyond submission of a dossier for marketing authorisation. We recommend that regulatory input should be initiated early on, but we can usually help at any stage of project development. Medwisdom can provide strategic guidance as well as practical feedback. Our input may highlight a new regulatory avenue, leading to a more efficient development plan.

With our extensive practical experience in regulatory affairs, the Medwisdom team understands and can interpret regulatory scenarios for clients.

Areas covered by Medwisdom’s regulatory affairs consulting include:

Project management input

Review of project plans

Monitoring of project progress

Reports to management on status

Strategies for expedient development

Regulatory affairs input

Development of a regulatory strategy

Interpretation of guidelines

Opinions on regulatory requirements

Technical-regulatory advice

Requirements for Chemistry manufacturing control/Labelling/Administrative/Clinical/Nonclinical

Scientific advice meetings at national agencies