Regulatory Strategy & Development Planning

Making the most of every piece of the regulatory puzzle.

When it comes to clinical development, we’re dedicated to getting every moment right. And we have the people to get you there. The seasoned advisors on our Regulatory Consulting Services team have decades of experience helping teams interpret new and existing guidance throughout the process – and throughout the world. In fact, many of them are former FDA, EMA, and NMPA regulators themselves. 

Our services include:

  • Regulatory Strategy: Global product development strategy, clinical, non-clinical, CMC, and regulatory gap analysis, due-diligence, product and indication prioritization, regulatory pathway optimization and acceleration strategy, global labelling (CCDS updates), marketing authorization applications (US, EU, China, Japan, Canada, and emerging markets-ROW), submission planning (eCTD), patient-focused development
  • Health Authority Meetings: Preparation support, briefing documents, rehearsals, meeting attendance, and health authority liaison
  • Quality system inspection: Strategy and inspection readiness
  • Submission support: Storyboarding/key messaging, core submission preparation and authoring, original application publishing with lifecycle maintenance, lifecycle publishing, global dossier management, RTQs, and CTA core dossier development
  • Stakeholder Management: Drug safety, technical operations, medical and commercial stakeholder management
  • Mergers and Acquisitions: Planning, submission authoring, dossier collection, and stakeholder management
WHITE PAPER / COMMERCIALIZATION

HOW CAN THE BIOSIMILAR CONCEPT BE APPLIED TO MORE COMPLEX PROTEINS SUCH AS MONOCLONALS?

An overview of the biosimilar concept, focused on the European Union's approval process for "similar biological medicinal products."

Learn More

Regulatory services brochure

PAREXEL Master Icons_LIME_RGB_Brochure.png

Regulatory, Development and Commercial 
Expertise. Operational Excellence. One Source.

View Now

FDA Releases Long-Awaited Guidance on 3-D Printed Products

Read Article

Regulatory & Commercial Guidance on PDUFA VI: Interpretation, Strategy & Implementation

Read Article

FDA Revises Surveillance Inspection Program, Implements New Communication Timelines, and Clarifies Roles and Responsibilities

Read Article

ICH Q12 to Step 2, Regional Publication to Follow

Read Article

EMA Updated First-in-Human Guidance Effective February, 2018

Read Article

We are always available for a conversation.

*