Services

Expedited Regulatory Pathways

A special thanks to this team for the hard work put into hitting this milestone – this was nothing short of remarkable.

VP, Global Regulatory Affairs

Large Pharma

Expedited regulatory pathways offer sponsors the opportunity to bring promising therapies to patients faster, but navigating these routes requires strategic planning, early engagement, and a clear understanding of regulatory expectations.

Whether you’re considering Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval, success depends on aligning your development programme with the right evidence, endpoints, and submission strategy.

When Should You Apply for Fast Track?

Sponsors can request Fast Track designation as early as the initial IND submission, provided there is strong nonclinical data supporting the programme and the product is intended to treat a serious condition with unmet medical need. The FDA welcomes Fast Track applications based on nonclinical evidence, such as activity in animal models, mechanistic rationale, or pharmacologic data. Early engagement with the agency increases the likelihood of shaping endpoints, data strategy, and CMC plans to support accelerated approval.

Navigating Expedited Pathways

From Fast Track and Breakthrough Therapy to Accelerated Approval and PRIME, we help sponsors determine eligibility, prepare robust requests, and engage effectively with global health authorities to bring critical therapies to patients sooner.

How MMS Services Can Help with Expedited Pathways

Pathway Mapping & Eligibility Assessment

Guidance on timing and qualification for Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval.

Regulatory Strategy & Agency Engagement

Planning and facilitating early and frequent meetings with regulatory authorities to align study design, endpoints, and submission approach

Parallel US–EU Strategy

Tailored support for FDA, EMA, and UK expedited programmes, including PRIME and Conditional Marketing Authorisation.

Rolling Review & Priority Review Readiness

Orchestrating content, timelines, and reviewer Q&A playbooks for compressed review cycles.

Statistical & Endpoint Strategy Across Phases

Designing Phase I-III studies and validating surrogate endpoints to keep expedited options open.

Data Standards & Submission Excellence

Ensuring SDTM/ADaM data quality, reviewer guides, and rapid response to agency requests.

CMC & Labelling Alignment

Coordinating Module 3 completeness and mapping clinical claims to evidence for accelerated submissions.

Real-World Impact

Case Study: Flexible Medical Writing Pool for Mid-Sized Pharma

To meet fluctuating portfolio demands, MMS provided a flexible pool of up to 9 FTEs. Our team authored a wide range of clinical documents—including high-complexity protocols—while meeting expedited timelines and adapting quickly to shifting priorities.

A Practical Guide to Expedited Regulatory Pathways

Get clear, practical guidance on navigating FDA and EMA expedited pathways. In this on-demand session, MMS experts break down how to accelerate development with smarter study design, strong data strategies, and informed regulatory planning.

Let’s Talk

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About MMS

MMS is an award-winning, data-focused CRO with 18+ years of experience supporting pharmaceutical and biotech companies. Our medical writing experts bring deep domain knowledge, strong communication skills, and a drive to deliver from day one.