Regulatory Affairs

• Assistance in the implementation of electronic publishing and document management systems.
• Oversight and/or implementation of the selected solution. Definition of system specifications. Assistance in system validation.
• Assistance in the compilation and management of submissions, in paper, eCTD, or Non-eCTD Electronic Submission (NEES) formats.

• Strategic writing of briefing documents (required for meetings with regulatory agencies), IND and CTAs, and clinical summaries and overviews included in registration dossiers.
• Document authoring, update, and review of regulatory submissions using company templates and style guides, or Viglya templates and style guide, to create submission-ready documents, such as:

– Clinical: Protocols, Clinical Study Reports, Investigator’s Brochures;
– Regulatory: IND Annual Reports, NDA Reports;
– Safety: Development Safety Update Reports (DSURs), PSURs;
– Labeling: Core Data Sheet (CDS), Core Safety Information (CSI), local product information (eg, U.S. Package Insert, European SPC).

• Technical and scientific review and quality control of regulatory applications.

Assistance in the definition and implementation of processes and procedures relevant to the creation, review, and approval of promotional and advertising materials. Authoring of policies and SOPs; training delivery.

Regulatory review of promotional copies and publications to meet business objectives, while ensuring the necessary level of regulatory compliance and adherence to client policies.

Monitoring of emerging trends, (draft) policies, regulations, and guidance that might impact and affect the client’s products and business.

Review, interpretation, and communication of the assessment of new regulatory requirements and guidelines specific to products and therapeutic areas. Analysis of the impact of changes on a compound’s clinical development and life cycle management.