Principal Consultant: A. Leander Fontaine, MD

In cooperation, as required, with associate consultants with outstanding expertise in the fields of labeling, pharmacovigilance, risk communication, reporting and labeling terminologies, and system evaluation/auditing

Also as "add-on" to non-specialized consulting organizations where labeling-specific expertise is required

Our Policy

Providing exceptional experience and showing solutions
Respecting the sensitive nature of consulting in the area of labeling

Consulting Areas

1. Processes, Organization, Policies

Global labeling system design (process, organization, policies, business rules)
Setting up labeling departments
Labeling decision making structure for development products and postmarketing labeling changes
Designing the interface between safety evaluation and labeling process
Aligning developmental labeling and IB, incl. development core safety information
Company-internal control systems for worldwide safety labeling, role and features of Core Data Sheets
Headquarters-Affiliate interactions
Labeling quality control systems

Note: We offer a related seminar "Global Labeling Process Design and Evaluation: Good Labeling Process Practices - Evaluation - Auditing - Solutions".

2. Labeling Support Technology

Labeling project systems (management of requests, documentation of decisions, implementation tracking, integration in product knowledge bases)
Labeling databases and document management systems
Tracking and auditing systems
SPL and PIM integration into a global labeling system

3. Content and Format of Labeling

Content and implementation of core data sheets, labeling harmonization
Supporting rationales and documentation for core labeling changes
Development core safety information (for IB) and development core data sheets
Submission labeling for new products/indications
Designing and testing EU patient labeling
Complex labeling and regulatory situations - local and global