Over the years, outsourcing has become a popular trend with the medical device industry, allowing innovators to leverage the technical and regulatory expertise of contract service providers in order to expedite time to market
Roots Analysis is pleased to announce the publication of its recent study, titled, “Medical Device CROs for Regulatory Affairs Management Market, 2019-2030.”
The report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. The study features an in-depth analysis, highlighting the capabilities of the various CROs engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:
- A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain.
- A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies.
- An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America, Europe, Asia-Pacific and rest of the world.
- Elaborate profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies.
- A benchmark analysis, highlighting the key focus areas of very small-sized, small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups.
- An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.
- An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
- A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers.
- A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
- Medical Device Class
- Class I
- Class II
- Class III
- Therapeutic Area
- Cardiovascular Disorders
- CNS Disorders
- Metabolic Disorders
- Oncological Disorders
- Ophthalmological Disease
- Orthopedic Disorders
- Pain Disorders
- Respiratory Disorders
- Type of Regulatory Affairs Service
- Pharmacies GAP-Analysis
- Pharmacies Legal Representation
- Pharmacies Notified Body Selection
- Product Labelling-related Services
- Product Registration and Clinical Trial Applications
- Regulatory Document Submissions
- Regulatory Writing and Publishing
- Risk Management-related Services
- Technical Dossier Set-up
- Vigilance & Medical Device Report
- Key Geographical Regions
- North America
- Asia-Pacific and Rest of the World
Key companies covered in the report
- CTI Clinical Trial and Consulting Services
- MIC Medical
- North American Science Associates (NAMSA)
- Premier Research
- Société Générale de Surveillance (SGS)
- Underwriters Laboratory (UL)
For more information please click on the following link
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About Roots Analysis
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