OriPeutic BioServices HELPS YOU NAVIGATE THE REGULATORY LANDSCAPE THROUGHOUT THE PRODUCT LIFE CYCLE.

With increasing regulatory pressures, every phase of your process must be scrutinized. That’s what we do. Our consultants bring years of industry experience – we have walked in your shoes and understand your regulatory challenges (ex: CFR21, PAI, EMA...). We see the big picture, from application strategy through product approval and beyond.

RELY ON ABC TO GUIDE YOU THROUGH THE PROCESS OF PROMOTING REGULATORY SUCCESS.

OriPeutic BioServices provides guidance, expertise, and support for preparing, accurately submitting, and maintaining your regulatory filings to help you get your medicine to patients faster.

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

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

• 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, with years of life sciences industry experience (and many of whom have prior regulatory agency experience), guide the interpretation of regulatory requirements and industry guidelines. We share industry best practices to help you develop an effective and efficient resolution strategy to ensure high-quality regulatory submissions.