Parexel

★★★★★ 3.6 / 5
• 69 reviews

Parexel is a leading CRO offering end-to-end biopharmaceutical services, including clinical development, regulatory strategy, and market access planning to accelerate drug development and maximize market impact.

Parexel provides comprehensive biopharmaceutical services designed to guide clients through the entire drug development lifecycle. Their expertise spans portfolio optimization, early development and innovation, integrated clinical development (Phase I-IV), and approval and access strategies. They focus on delivering whole-study solutions with integrated strategies that ensure safety, data integrity, and regulatory compliance, while also designing patient-informed protocols to accelerate enrollment and successful drug launches. With a team of former regulators and HTA professionals, Parexel offers tailored regulatory, compliance, and market access strategies across specialized therapeutic areas. They aim to create customized pathways for maximizing global market reach and enhancing product value through post-approval studies and lifecycle management. Parexel emphasizes operational excellence, bringing together cross-functional experts to implement best practices, simplify processes, and standardize technology, thereby accelerating timelines and improving quality. They strive to offer the personalized approach of a small CRO with the extensive capabilities of a large one, dedicated to developing life-changing treatments.

About

**Who they are**
Parexel is a leading Contract Research Organization (CRO) that offers comprehensive biopharmaceutical services. They focus on accelerating drug development and maximizing market impact for their clients.

**Expertise & scope**
* End-to-end solutions spanning portfolio optimization, regulatory strategy, clinical trials (Phase I-IV), and market access planning.
* Integrated expert clinical, regulatory, and market access strategies to support informed risk-reward decisions.
* Multi-disciplinary early phase approaches to accelerate proof of concept by optimizing study design and generating robust clinical evidence.
* Whole-study solutions designed to ensure safety, data integrity, and regulatory compliance, with patient-informed protocols to accelerate enrollment.
* Tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, developed by former regulators and HTA professionals.

**Reputation / proof points**
* Coverage across US, EU, JP, AU.
* Supports multiple languages including English, German, French, Spanish, Japanese, and Chinese.

Additional information

Parexel's approach to regulatory compliance emphasizes integrating diverse expertise to optimize study design and generate robust clinical evidence. They design patient-informed protocols aimed at removing participation barriers and accelerating enrollment, thereby increasing the likelihood of successful drug launches. Their team, which includes former regulators and HTA professionals, provides customized pathways to maximize global market reach throughout a product's lifecycle.

Key Highlights

  • Offers end-to-end biopharmaceutical services including clinical development, regulatory strategy, and market access planning. Source
    “Explore end-to-end solutions throughout development — from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more.”
  • Provides integrated expert clinical, regulatory, and market access strategies. Source
    “Our team optimizes your portfolio utilizing integrated expert clinical, regulatory, and market access strategies, enabling earlier and more informed risk-reward decisions.”
  • Team includes former regulators and HTA professionals. Source
    “Our team of former regulators and HTA professionals provide tailored regulatory, compliance, and market access strategies...”

Certifications & Trust Signals

  • Global coverage including US, EU, JP, AU. Source
    “Coverage: US, EU, JP, AU”

Buyer Snapshot

Best for
  • Biopharmaceutical companies seeking end-to-end development support
  • Organizations needing integrated regulatory, clinical, and market access strategies
  • Companies focused on accelerating drug development timelines
How engagement typically works
  • Consultative approach to strategy development
  • Integrated team collaboration
  • Tailored pathway creation
Typical deliverables
  • Regulatory strategy and compliance plans
  • Optimized clinical trial designs
  • Market access planning
  • Patient-informed protocol development
Good to know
  • Best when requiring deep expertise in regulatory affairs and market access across multiple geographies.
HQ: Boston, US
Languages: English, German, French, Spanish, Japanese, Chinese
Timezones: EST, CST, PST, GMT, CET, JST
Claim status: Listed

Services & Capabilities

FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)

Jurisdictions: US, EU, JP, AU
Countries: US, UK, Germany, France, Japan, China
Industries: Medical Devices, IVD, Pharmaceuticals
Onboarding time: 7–14 days
Pricing model: Custom pricing
Service Types: QMSR/ISO 13485 Gap Assessment, SOP / Documentation Remediation, CAPA & Nonconformance Remediation, Supplier Controls / Quality Agreements, Internal Audit Program Upgrade, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start: flexible
Delivery Mode: Hybrid
Inspection Experience: Former FDA investigator on team, Supports mock inspections regularly, ISO 13485 lead auditor capability

Additional fda_qmsr_transition_inspection_readiness Details

Service Types
Regulatory strategy, Clinical development, Market access planning, Portfolio management, Value substantiation lifecycle management, Operational excellence, Medical affairs, Study start-up
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Former FDA investigator on team, Supports mock inspections regularly
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