REGULATORY AFFAIRS By offering a full range of expertise in Regulatory Affairs, Frameworks helps clients successfully navigate the complex and evolving regulatory environment from early development to post-commercialization.
We offer a comprehensive range of solutions in Regulatory Affairs to successfully help clients meet the challenges in drug development and product commercialization.Coupled withRegulatory Operations (submissions/publishing), we provide a complete end-to-end regulatory solution for both emerging biotech and commercialized pharmaceutical clients.
We offer a range of solutions from “Expert” regulatory strategic consulting to outsourced regulatory services to meet the challenges in drug development and product commercialization. Coupled with our Regulatory Operations (submissions/publishing) we provide a complete end-to-end regulatory solution for both Emerging Biotech and Commercialized Pharmaceutical Clients.
Global regulatory guidance and execution of strategy for all stages of development
Preparation, review and submission of documents to Health Authorities
Health Authority Meeting planning/preparation and management of responses
Ad Promo Review
Review and approval of all advertising and promotional materials
Collaborative participation in Medical, Legal Regulatory (MLR) Committees
Guidance for launch planning, advisory comments and interactions with OPDP
Assistance with the development and/or review of procedures and workflows
Services provided by a team of reviewers on either a full-time basis or as needed (to cover gaps in coverage)
Guidance on the creation and implementation of global labeling strategies for development and commercialized products
Development of Company Core Data Sheets (CCDS), EU Summary of Product Characteristics (SmPC), US Package Inserts, Medication guides, and Patient Information Leaflets
Management and support of Health Authority Information requests
Creation of labeling procedures and associated workflows
Development and execution of Global CMC strategy
Preparation and review of CMC content for submission to Health Authorities
Health Authority Meeting planning/preparation and management of CMC related responses