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2019-2030 Study on the Current Landscape of Contract Service Providers Focused on Regulatory Affairs Management for Medical Devices


Dublin, Jan. 03, 2020 (GLOBE NEWSWIRE) — The “Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030” report has been added to ResearchAndMarkets.com’s offering.

Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030 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.

One of the key objectives of this report was to evaluate the current opportunity and the future potential of the medical device regulatory affairs outsourcing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2019-2030.

In addition, we have provided the likely distribution of the opportunity across different:

  • [A] types of regulatory affair management service offered (legal representation, project registration and clinical trial application, regulatory writing and publishing and 6+ categories)
  • [B] device class (class I, class II and class III)
  • [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others)
  • [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world)

In 2018, the global medical devices market was estimated to have reached a net worth of approximately USD 450 billion. It is also worth noting that, since January 2018, the USFDA approved over 130 medical devices. However, a relatively large proportion of developers lack the resources and technical expertise required to handle regulatory filings and effectively manage the processes associated with procuring marketing authorizations from regional regulators.

Moreover, keeping up with evolving regulatory guidelines, rising costs of legal advice and increasing effort required for preparing of technical documentation, is difficult for companies with limited finances. In addition, establishing reimbursement strategies for medium to high-risk devices is also a complicated process and innovator companies usually do not have the expertise to deal with payers and insurance providers.

According to a recent report, 68% of medical device companies reports prepared and submitted by in-house players are either rejected or were reported to have multiple major gaps in their clinical evaluation report (CER) and supporting evidences by the notified bodies. In fact. in a survey published in the 2016 edition of Global Medical Device Supply Chain, regulatory requirements were highlighted among the primary areas of concern within the medical device value chain. Furthermore, the implementation of highly stringent regulatory guidelines, specifically for devices posing medium to high risk to consumers, render them subject to rigorous quality assessments.

The aforementioned challenges have led many medical device developers, especially the smaller players and certain established companies as well, to outsource parts of their regulatory operations to capable contract research organizations (CROs). Generally, CROs are known to offer a number of benefits, which include cost benefits, reductions in time-to-market and, in this specific case, an in-depth and up-to date regulatory support. Given that the global demand for medical devices is increasing at a substantial pace, the opportunity for CROs with expertise in regulatory affairs management is also on the rise.

In the foreseen future, the growing complexity of regulatory processes across various developing and developed geographies is likely to prompt more developers to outsource various aspects of their dealings with regulatory authorities. Moreover, in order to cope up with latest changes in medical device-related regulations, several legacy CROs are re-evaluating their operational models and business strategies. Owing to the anticipated rise in demand for such services, the contract regulatory services domain is likely to witness the entry of a number of new players in the foreseen future.

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, 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, and popular therapeutic area(s).
  • 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 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.

To account for the uncertainties associated with the growth of the medical device regulatory affairs outsourcing CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

Key Topics Covered

1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines


3.1. Chapter Overview
3.2. Contract Research Organizations (CROs)
3.2.1. Evolution of CROs
3.3. Role of CROs in the Medical Device Industry
3.4. Types of Medical Device CROs
3.5. Types of Services Offered by CROs
3.5.1. Types of Regulatory Affairs-Related Services Offered by CROs
3.6. Need for Outsourcing Regulatory Affairs-Related Operations for Medical Devices
3.7. Key Considerations for Selecting a Suitable CRO Partner
3.8. Advantages of Working with CROs
3.9. Risks and Challenges Related to Working with CROs
3.10. Concluding Remarks

4.1. Chapter Overview
4.2. Overview of Medical Device Supply Chain
4.2.1. Importance of Regulatory Affairs in Medical Device Supply Chain
4.3. Factors Affecting the Medical Device Supply Chain
4.4. Key Performance Indicators for Medical Device Supply Chain Management
4.5. Optimization of Regulatory Affairs in the Medical Device Supply Chain
4.5.1. Digitalization of the Medical Device Supply Chain

5.1. Chapter Overview
5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
5.3. Regulatory and Reimbursement Landscape in North America
5.3.1. The US Scenario
5.3.2. The Canadian Scenario
5.3.3. The Mexican Scenario
5.4. Regulatory and Reimbursement Landscape in Europe
5.4.1. Overall Scenario
5.4.2. The UK Scenario
5.4.3. The French Scenario
5.4.4. The German Scenario
5.4.5. The Italian Scenario
5.4.6. The Spanish Scenario
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
5.5.1. The Australian Scenario
5.5.2. The Brazilian Scenario
5.5.3. The Chinese Scenario
5.5.4. The Indian Scenario
5.5.5. The Israeli Scenario
5.5.6. The Japanese Scenario
5.5.7. The New Zealand Scenario
5.5.8. The Singaporean Scenario
5.5.9. The South Korea Scenario
5.5.10. The South African Scenario
5.5.11. The Taiwanese Scenario
5.5.12. The Thailand Scenario
5.6. Comparison of Regional Regulatory Environment
5.7. Concluding Remarks

6.1. Chapter Overview
6.2. CROs Offering Regulatory Affairs-Related Services for Medical Devices: List of Companies
6.2.1. Analysis by Year of Establishment
6.2.2. Analysis by Size of Employee Base
6.2.3. Analysis by Location of Headquarters
6.2.4. Analysis by Area of Specialization
6.2.5. Analysis by Type of Regulatory Affairs-Related Service Offered
6.2.6. Analysis by Type of Additional Services Offered
6.2.7. Analysis by Device Class
6.2.8. Analysis by Type of Clientele
6.2.9. Analysis by Medical Device Regulatory Compliance Authorities
6.2.10. Analysis by Region of Operation
6.2.11. Analysis by Popular Therapeutic Areas
6.3. Concluding Remarks

7.1. Chapter Overview
7.2. CROs Headquartered in North America
7.3. CROs Headquartered in Europe
7.4. CROs Headquartered in Asia-Pacific and Rest of the World

8.1. Chapter Overview
8.2. Benchmark Analysis: Methodology
8.3. Region-wise Benchmark Analysis
8.3.1. North America, Peer Group I
8.3.2. North America, Peer Group II
8.3.3. North America, Peer Group III
8.3.4. North America, Peer Group IV
8.3.5. Europe, Peer Group V
8.3.6. Europe, Peer Group VI
8.3.7. Europe, Peer Group VII
8.3.8. Europe, Peer Group VIII
8.3.9. Asia Pacific and Rest of the World, Peer Group IX
8.3.10. Asia Pacific and Rest of the World, Peer Group X
8.3.11. Asia Pacific and Rest of the World, Peer Group XI
8.3.12. Asia Pacific and Rest of the World, Peer Group XII
8.4. Concluding Remarks

9.1. Chapter Overview
9.2. Guiding Models for Regulatory Outsourcing
9.2.1. Functional Service Providers (FSP) Model: Large Medical Device Developers
9.2.2. End-to-End Model: Small-Sized Medical Device Developers
9.2.3. Hybrid Model: Mid-Sized Medical Device Developers

10.1. Chapter Overview
10.2. Definition and Importance of Key Performance Indicators
10.3. Key Considerations for Selection of Key Performance Indicators
10.4. Types of Key Performance Indicators
10.4.1. Financial Indicators
10.4.2. Process / Capability Indicators
10.4.3. Market Reputation Indicators
10.5. Comparison of Key Performance Indicators
10.6. Concluding Remarks

11.1 Chapter Overview
11.2. Forecast Methodology and Key Assumptions
11.3. Overall Medical Device Regulatory Affairs Outsourcing Market, 2019-2030
11.4. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Geography, 2019 and 2030
11.5. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service, 2019 and 2030
11.6. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class, 2019 and 2030
11.7. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area, 2019 and 2030
11.8. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Type of Regulatory Affairs-Related Service and Geography
11.9. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Device Class and Geography
11.10. Medical Device Regulatory Affairs Outsourcing Market: Distribution by Therapeutic Area and Geography

12.1. Chapter Overview
12.2. Key Takeaways

13.1. Chapter Overview
13.2. Company Specifics of Respondents
13.3. Designation of Respondents
13.4. Types of Regulatory Affairs-Related Services
13.5. Analysis by Region of Operation
13.6. Type and Size of Clientele
13.7. Average Number of Projects
13.8. Proportion of Clients Outsourcing Regulatory Affairs-Related Services
13.9. Cost of Outsourcing Regulatory Affairs-Related Services
13.10. Current and Future Market Opportunity

14.1. Chapter Overview
14.2. A+ Science
14.2.1. Company Snapshot
14.2.2. Interview Transcript: Tania Persson, Business Development Manager
14.3. AtoZ-CRO
14.3.1. Company Snapshot
14.3.2. Interview Transcript: Alexa Foltin-Mertgen, Business Development Manager
14.4.1. Company Snapshot
14.4.2. Interview Transcript: Troy Mccall, Chief Operating Officer
14.5. CW Research & Management
14.5.1. Company Snapshot
14.5.2. Interview Transcript: Christian Wolflehner, Managing Director, Clinical Trial Specialist
14.6. HungaroTrial
14.6.1 Company Snapshot
14.6.2. Interview Transcript: Antal Solyom, Director of Medical Device Unit
14.7. Metrics Research
14.7.1 Company Snapshot
14.7.2. Interview Transcript: Dr. Nazish Urooj, Senior Manager, Medical & Clinical Operations
14.8. Vyomus Consulting
14.8.1 Company Snapshot
14.8.2. Interview Transcript: Dr. C Omprakash, Technical Director and Partner



  • 1MED SA
  • 4Clinics
  • A+ Science
  • Abbott
  • Accell Clinical Research
  • Accredited Consultants
  • Accutest Global
  • Acorn Regulatory Consultancy Services
  • Acrapack
  • acromion
  • aCROss Medical
  • Activa Cro
  • Actolis
  • ADAX International
  • Advanced Medical Research (AMR)
  • Advena
  • AE Performance Testing Lab
  • Affinity Bio Partners
  • Afra Pharma Consultant
  • AG Mednet
  • Aginko Research
  • Al Tamimi
  • Allied Clinical Management
  • Allscripts Healthcare Solutions
  • Alquest
  • Amarex
  • American Preclinical Services
  • AmeRuss
  • Amritt
  • analyze & realize
  • Andaman Medical
  • Anteris Medical
  • A-pharmaconsult
  • apices
  • APO Plus Station
  • Appletree CI Group
  • Arazy Group Consultants
  • ARC Pharma
  • Archemin
  • Arlenda
  • ARQon
  • Asia Actual
  • AtoZ-CRO
  • Australian Healthcare Solutions
  • Auxilife Scientific Services
  • AVIAD Life Sciences
  • Axonal-Biostatem
  • Azelix
  • Barons Medical Consulting
  • Beaufort
  • Becton Dickinson
  • Beijing JRJ Science and technology
  • BIC Group
  • BioAgile Therapeutics
  • BIOCODEX Nordics
  • BioFortis
  • Biomapas
  • Biomedical Regulatory Consulting
  • Biomedical Strategy
  • BioMotiv
  • BioPlan
  • Biorasi
  • Bioreg Services
  • Bioscience
  • Biotech Regulatory Solutions
  • BioTeknica
  • BiTrial Clinical Research
  • BLAU Pharmaceutical Service
  • Boston Biomedical Associates (BBA)
  • Boston MedTech Advisors
  • Boston Scientific
  • Brandwood CKC
  • Bridge Pharm
  • BSI
  • Cactus Global
  • Cardinal Health
  • CardioMed Device Consultants
  • Cardiovascular European Research Center (CERC)
  • CARSL Consulting
  • Catawba Research
  • Cato Research (CATO)
  • CC Clinical research Consultants
  • Ceetox
  • C’en Al Research
  • CHA Medical Group
  • Charles River Laboratories
  • Chemical Inspection and Regulation Service (CIRS)
  • China Med Device
  • Chris Freer Associates
  • Clarivate Analytics
  • ClinAudits
  • ClinDatrix
  • Clinical Device Group
  • Clinical Research & Compliance Consulting
  • Clinical Trial Data Services
  • CliniExperts
  • Clinilabs
  • Clinipace
  • Clinlogix
  • Clinmark
  • ClinMed Pharma
  • ClinSync
  • Clintec
  • CMIC Group
  • CMX Research
  • Cobridge
  • Commercial Eyes
  • ComplianceAcuity
  • Complya Consulting
  • Consultys Switzerland
  • Convex
  • Costello Medical
  • Courante Oncology
  • CPS Cortex
  • Creganna Medical
  • Criterium
  • Cromos Pharma
  • CROs NT
  • Crown CRO
  • CSSi LifeSciences
  • CTI
  • CTNT
  • CurAccel
  • CW Research & Management
  • CYA Medical Device Consulting
  • Dalia Givony, Regulatory & Clinical Consulting
  • Databean
  • Datapharm Australia
  • Datavant
  • Datavant
  • De Groot Technical Services
  • devicia
  • DH RegSys
  • dicentra
  • DiscGenics
  • DKSH Marketing Services Spain
  • dMed
  • Donawa Lifescience Consulting
  • Dor Pharmaceutical Services
  • DP Clinical
  • DSA Consultants
  • DuPage Medical Group
  • EAS Consulting Group
  • EG Mont Brazil
  • Eli Lily
  • Emergo
  • Engel, Hellyer & Partners
  • EPIC Research
  • Essilor
  • ESTERN Medical
  • Ethicare
  • EuDRAcon
  • Eurofins Scientific
  • Eurotrials
  • Evidilya
  • Exalon
  • ExecuPharm
  • Factory CRO
  • FDAInsight
  • Fermish Clinical Technologies
  • FGK Clinical Research
  • FMD K&L
  • Focal Point Research
  • Fountain Medical Development (FMD)
  • Fresenius Medical Care
  • Freyr
  • GCP-Service International
  • GE Healthcare
  • genae
  • Genco Medical
  • Genelife Clinical Research
  • Genpact
  • George Clinical
  • Getz Healthcare
  • GKM
  • Global Pharma Tek
  • Global Regulatory Affairs (GRA)
  • Global Regulatory Partners
  • Global Regulatory Services
  • Green Building Japan (GBJ)
  • Grove Group
  • Gsap
  • Gulf Medical Devices Consultancy
  • Health Advances
  • Health Sciences
  • Healthcare International Partners
  • HealthLink
  • HingeClinica
  • HungaroTrial
  • ICBio
  • ICON
  • ICRC-Weyer
  • ICTA
  • idcOnic
  • Illingworth Research Group
  • INE G-MED (through G-MED North America)
  • Innomar Strategies (a part of AmerisourceBergen)
  • Inrextest
  • Integrated Resources CRO Division
  • Intel
  • International HealthCare (IHC)
  • Intertek Group
  • Ipsum
  • Iris Pharma
  • Ironstone Product Development
  • IRW
  • ITEC Services
  • IVDeology
  • IZiel Healthcare
  • J Knipper
  • Japan MDC (JMDC)
  • Johnson & Johnson
  • JSS Medical Research
  • KCR
  • KCRI
  • KD&A
  • Ken Block Consulting
  • Kensington Swan
  • Keystone Regulatory Services
  • Kiana Systems
  • Kinapse
  • Knoell
  • Kobridge Consulting
  • KPS Clinical Services
  • L.S Marketing & Registration
  • LabCorp
  • Lambda Therapeutic Research
  • Larix
  • Lean RAQA
  • Leon Research
  • Li-Med RA & QA Experts
  • Linical
  • LINK Medical
  • LNAge
  • MakroCare
  • Malca Chen-Zion Group
  • MANDALA International
  • Mapi Group
  • MasterControl
  • McCarthy Consultant Services
  • McGee Pharma International (MPI)
  • McMillan Research
  • MD101 Consulting
  • MD-Clinicals
  • mdi Consultants
  • mdi Europa
  • MDP Solutions
  • MED Institute
  • Medelis
  • Medfiles Group
  • Medical Equipment Compliance Association
  • Medidee
  • MeDiNova Research
  • MediqTrans
  • Meditrial
  • Meditrial Europe
  • MedNet
  • Medpace
  • MedPass International
  • MedQ Consultants
  • Medtronic
  • Medvance
  • Meiji Pharmaceutical University (MPU)
  • Mene Research
  • Mericon
  • Meshayu Consultants
  • MethodSense
  • Metrics Research
  • MIC Medical
  • Micren Healthcare
  • Microsoft
  • Mid-Link Consulting
  • Mn Solutions
  • Mobius Medical
  • MolecularMD
  • Morley Research Consortium
  • Morula HealthTech
  • Musculoskeletal Clinical Regulatory Advisers (MCRA)
  • Navitas Life Sciences
  • NCGS
  • NEOMED Services
  • Neopharm
  • Neox Clinical Research
  • Neozene
  • Nerac
  • New England Research Institutes (NERI)
  • NHP Consulting
  • Nordic Health Economics AB (NHE)
  • Northlane Capital Partners
  • Northside consulting
  • Novartis
  • NovaTrials
  • Novem Healthcare
  • Novotek
  • Novum
  • NSF International
  • Nyprax Pharma
  • O4 Research
  • Obelis Group
  • OmniComm Systems
  • Onorach
  • Operon Strategist
  • OPIS
  • Ora
  • Osmunda
  • Pace Analytical
  • Pacific Bridge Medical
  • Pacific Clinical Research Group (PCRG)
  • Parexel
  • PAREXEL Biotech
  • Paxmed Interational
  • Pearl Pathways
  • Pepgra
  • Perfect Pharmaceuticals Consultants
  • Perfection-CRO
  • Pharma to Market
  • Pharmaceutical Regulatory Services
  • Pharmaceutical Solutions
  • Pharmaco-Kinesis
  • Pharmahungary Group
  • PharmaLex
  • PharmaMed Global (through AJW Technology Consultants)
  • PharmaMed Research
  • PharmDedict
  • PharmEng Regulatory Affairs
  • PharmOut
  • Phidea Group
  • Pivotal
  • PPD
  • PQE Group
  • PRA International
  • Practice Fusion
  • PRC Clinical
  • Precision Medicine Group
  • Premier Research
  • Professional Regulatory Affairs
  • Profil
  • Promedica International
  • ProMedoss
  • ProPharma Group
  • Prosoft Clinical
  • ProTrials
  • Proxima Clinical Research
  • Pharmaceutical and Regulatory Services (PRSG)
  • Q&R Canada
  • QA Consulting
  • QAdvis
  • Qmed Consulting
  • Qserve Group
  • QST Consultations
  • Q-Trials
  • Qualitiso
  • Qualtech Consulting
  • Quanticate
  • Quantum Solutions India
  • Quantum Solutions India (QSI)
  • R & C Consulting Group
  • R&G PharmaStudies
  • R&Q
  • RCQ Solutions
  • RCRI
  • ReadyClinical
  • Reg-Affairs & QualiPractixis
  • RegDesk
  • Registrar Corp
  • Regulatory Compliance Associates
  • Regulatory Insight
  • Regulatory Professionals
  • Reimbursement Strategies
  • Research Professionals
  • RGL Research
  • Rho
  • Rook Quality Systems
  • RQSolutions
  • RTI Health Solutions
  • Safis Solutions
  • Samsung Medical Center
  • Saudi Telecom Company (STC)
  • Scandinavian CRO
  • Scandinavian Regulatory Services (SRS)
  • Scope International
  • SeerPharma
  • Sentez CRO
  • Seoul CRO
  • SEQ
  • SGS
  • Shanghai QiSheng Business Consulting
  • SHYFT Analytics
  • Sidley Austin
  • Siemens
  • Simmons & Simmons
  • Sipra Labs
  • Sixmurs Group
  • Society for Clinical Research Sites
  • Southern Star Research
  • SPharm
  • StarFish Medical
  • STATKING Clinical Services
  • SteriPack Group
  • SterlingBio
  • Strategic Compliance International
  • StrugoPharm
  • Stryker
  • Sumika Chemical Analysis Service (SCAS)
  • SunFlare
  • Symbioteq
  • Syneos Health
  • Syntax
  • Synteract
  • TAB Clinical
  • TCA Clinical Research
  • TechnoSTAT
  • Telecommunications Industry Association (TIA)
  • The CLINICAL TRIAL Company Group
  • The CRO Group
  • The Integra Group
  • The Society for Clinical Research Sites (SCRS)
  • The Weinberg Group
  • Thema Med
  • Theo Manufacturing
  • TheraGenesis
  • TPIreg
  • TRAC
  • TransPerfect Life Sciences
  • Trial Form Support International (TFS) (Acquired by Ratos)
  • Turacoz Healthcare Solutions
  • TV SD-Healthcare & Medical Devices
  • UBC
  • Ulmer Ventures
  • Underwriters Laboratory (UL)
  • Unikal Consultants
  • Vantage BioTrials
  • Vantage Consulting International
  • Venn Life Sciences
  • Veristat
  • VOLER Biotech Consulting
  • Volv
  • Vyomus Consulting
  • WCCT Global
  • Wipro
  • Wonderville
  • Wuxi AppTec
  • Zeincro
  • Zi-Medical
  • Zimmer Biomet
  • Zwiers Regulatory Consulting

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