Parexel
★★★★★
3.4
/ 5
•
79 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.
**Expertise & scope**
* End-to-end solutions across the drug development lifecycle, including portfolio optimization, regulatory strategy, clinical trials (Phase I-IV), and market access planning.
* Integrated expert clinical, regulatory, and market access strategies to facilitate 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 and increase successful drug launches.
* Tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, developed by former regulators and HTA professionals to maximize global market reach.
**Reputation / proof points**
* Offers services across US, EU, and JP geographies.
* Supports multiple languages including English, German, French, Spanish, Japanese, and Chinese.
Parexel is a leading Contract Research Organization (CRO) that offers comprehensive biopharmaceutical services.
**Expertise & scope**
* End-to-end solutions across the drug development lifecycle, including portfolio optimization, regulatory strategy, clinical trials (Phase I-IV), and market access planning.
* Integrated expert clinical, regulatory, and market access strategies to facilitate 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 and increase successful drug launches.
* Tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, developed by former regulators and HTA professionals to maximize global market reach.
**Reputation / proof points**
* Offers services across US, EU, and JP geographies.
* Supports multiple languages including English, German, French, Spanish, Japanese, and Chinese.
Additional information
Parexel's approach to regulatory compliance emphasizes integrated strategies that span the entire product lifecycle. They focus on building patient insights into asset development and claims, which can be crucial for navigating complex regulatory landscapes and ensuring market access. Their services are designed to optimize study design, accelerate enrollment through patient-informed protocols, and ultimately increase the likelihood of successful drug launches. Buyers can expect a focus on data integrity and safety throughout the development process.
Key Highlights
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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.”
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Provides integrated strategies for regulatory compliance, safety, and data integrity.
Source
“We deliver whole-study solutions with integrated strategies that ensure safety, data integrity, and regulatory compliance.”
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Leverages former regulators and HTA professionals for tailored strategies.
Source
“Our team of former regulators and HTA professionals provide tailored regulatory, compliance, and market access strategies...”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Biopharmaceutical companies seeking end-to-end development support
- Organizations needing integrated regulatory, clinical, and market access strategies
- Firms requiring patient-informed protocol design to accelerate enrollment
How engagement typically works
- Collaborative strategy development
- Integrated multi-disciplinary teams
- Tailored regulatory and compliance pathways
Typical deliverables
- Optimized portfolio strategies
- Robust clinical evidence generation
- Patient-informed study protocols
- Market access and regulatory compliance plans
Good to know
- Best when requiring comprehensive support across the product lifecycle.
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 and asset valuation, Early development and innovation, Integrated clinical development, Approval and access, Value substantiation lifecycle management, Operational excellence, Medical affairs, Study start-up, Building patient insights into assets, profile and claims
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Former FDA investigator on team, Supports mock inspections regularly
