How We Help

Regulatory Affairs

We offer a comprehensive range of solutions in Regulatory Affairs to successfully help clients meet the challenges in drug development and product commercialization.  Coupled with  Regulatory Operations (submissions/publishing), we provide a complete end-to-end regulatory solution for both emerging biotech and commercialized pharmaceutical clients. 

Principal
Jennifer Harakal

Jennifer Harakal
EVP, Regulatory Affairs

Principal
Jennifer Harakal

Jennifer Harakal
EVP, Regulatory Affairs

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.

Strategy

  • 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

  • Lifecycle Management

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)

Labeling

  • 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

CMC

  • 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

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Transformation through Collaboration