Regulatory Consulting

TUNNELL HELPS YOU NAVIGATE THE REGULATORY LANDSCAPE THROUGHOUT THE PRODUCT LIFE CYCLE

With increasing regulatory pressures it is critical that every phase of your process is scrutinized. That’s what we do. Our consultants bring years of industry experience – we have walked in your shoes and we understand your regulatory challenges. We see the big picture, from application strategy through product approval and beyond.

RELY ON TUNNELL TO GUIDE YOU THROUGH THE PROCESS TO PROMOTE REGULATORY SUCCESS

Tunnell provides the guidance, expertise and support for the preparation, accurate submission and maintenance of your regulatory filings to help you get your medicine to patients faster.

REGULATORY SUBMISSION SUPPORT

Regulatory submission support including CMC authoring and publishing, PAI readiness assessment, post marketing CMC management including supplements, changes being effected and annual reports.

REGULATORY STRATEGY

Regulatory consulting including CMC strategy, filing strategy, comparability protocols, specification development and preparation for and participation in agency meetings.

PRODUCT DEVELOPMENT

Product development guidance including application and review of Quality-by-Design (QbD), question-based development and continued process verification.

SUSTAINABLE RESULTS

Our seasoned and highly credentialed consultants, who possess years of life sciences industry experience (and many of whom have prior regulatory agency experience) provide guidance regarding interpretation of regulatory requirements and industry guidelines. We share industry best practices to help you develop an effective and efficient resolutions strategy to ensure high quality regulatory submissions.

Published

Conrad J. Heilman, Jr., Ph.D., Joseph J.Villafranca, Ph.D. – BioPharm International – January, 2008