To order this detailed 550+ page report, please visit this -
https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html
Key Inclusions
§
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,
and detailed analysis based on a number of relevant parameters, such as year of
establishment, size of employee base, geographical location, device class
(class I, class II, and class III), type and size of clientele (medical device
developers, medical device manufacturers, medical device research
organizations, and others), types of services offered, ([A] regulatory
management services (such as legal representation, notified body selection,
project registration and clinical trial application, regulatory writing and
publishing, regulatory document submission, product labelling related service,
gap-analysis, technical dossier set-up, vigilance & medical device report,
risk management-related services), [B] additional services (such as
biostatistics, consulting, clinical operations, post-marketing activities,
quality assurance, reimbursement, training)), region(s) of operation wherein
the company is offering regulatory management services.
§
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 (such as artificial intelligence, big
data analytical, blockchain, internet of things and others).
§
An elaborate
discussion on the various guidelines established by major regulatory bodies for
medical device approval across North America (the US, Canada and Mexico),
Europe (France, Germany, Italy, Spain, the UK and rest of Europe), Asia-Pacific
and rest of the world (Australia, Brazil, China, India, Israel, Japan, New
Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The
report also features an insightful multi-dimensional, heat map analysis,
featuring a comparison of the contemporary regulatory and reimbursement
scenarios in key geographies across the globe.
§
Elaborate profiles of
popular players that specialize in offering end-to-end regulatory services for
medical devices across key geographies (North America, Europe and
Asia-Pacific). Each profile features a brief overview of the company, including
information on company headquarters, year of establishment, number of
employees, and therapeutic area expertise, financial information (if
available), detailed description of service portfolio, and an informed future
outlook.
§
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, providing a means for stakeholders to identify
ways to gain a competitive edge in the industry.
§
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.
The report also features the likely
distribution of the current and forecasted opportunity across important market
segments, mentioned 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
- Others
§
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
- Europe
- Asia-Pacific and Rest of the World
To request sample pages, please visit this -
https://www.rootsanalysis.com/reports/282/request-sample.html
Key Questions Answered
§
Who are the leading CROs offering regulatory affairs-management
services for medical devices?
§ What
are differences in regulatory guidelines for medical device approval, across
various geographies?
§ What
are the key performance indicators used by sponsors to evaluate potential service
providers?
§ What
are the popular outsourcing models used by medical device companies for regulatory
affairs-management purposes?
§ What
are the key challenges faced by medical device developers / manufacturers in
terms of regulations related to medical device approvals?
§ How
is the current and future market opportunity likely to be distributed across
key market segments?
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Contact
Us
Gaurav
Chaudhary
+1
(415) 800 3415
gaurav.chaudhary@rootsanalysis.com
