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MEDICAL DEVICE
SERVICES
2020
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Turacoz is an ISO Certified
9001:2008 medical writing,
training and consultancy
company working with top
MNCs (medical device,
pharmaceutical, biotech,
invitro diagnostics, consumer
care, cosmetics and
aesthetics) and research
institutes and healthcare
professionals globally.
i
Founded in: 2014
Founder:
Dr Namrata Singh
Headquarters:
India
Registered offices:
The Netherlands, Singapore,
Toronto and New Jersey
Number of clients
端 Industry: 35
端 Research institutes: 82
Employees: 100+
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT US
Regulatory
affairs
team
Scientific
and
Medical
Team
Account
Managers
and Project
Managers
Quality Check
Specialist
Graphic
Designing and
E-learning
Development
team
TURACOZ TEAM
MEDICAL DIRECTOR
04
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT US
P e r f e c t i o n
P e o p l e
P l a n e t
端 Robust recruitment process and skill/experience mapping
端 Continuous professional development in form of internal and external trainings
端 Can work onsite and offsite
端 Technical team available for all major time zones
端 Focus on productivity and overall efficiency
端 Work as strategic partners and not only as vendors
端 Stringent process to maintain quality and meet timelines
端 Prompt project management
端 Customized solutions based on client requirements/unmet need
端 80% is repeat business
端 Goal is to create sustainable business
端 CSR and environment friendly initiatives
端 Spread health and lifestyle awareness regularly through blogs/social
media/events/partnerships
端 Women empowerment activities
HAPPY TEAM ALWAYS LEADS TO HAPPY CLIENTS
WHY TURACOZ
05
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT US
Regulatory affairs
consulting and writing
Scientific
communications
Medical
Education
SERVICE SPECTRUM
07
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Regulatory affairs
consulting and writing
08
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Compliant with the MEDDEV
and MDR.
Our clinical evaluation
services are based on:
 Currently available
scientific literature
 Completed clinical
investigations
 Conformity assessment to
determine safety and
performance of devices
US, EU, INDIA, ASEAN, CANADA, LATAM
Regulatory Strategy and Consultancy
Technical documentation
QC of regulatory documents
Regulatory submission and responses
REGULATORY AFFAIRS CONSULTING AND WRITING
09
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
REGULATORY STRATEGY AND CONSULTANCY
Gap analysis and compliances of region-specific
regulations
Pre-submission queries to regulatory agencies
Regulatory submissions
Responses to queries from regulatory authorities
EU MDR consulting services to support transition to
the new regulations
10
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
TECHNICAL DOCUMENTATION
510(k) submission or
Pre-market approval
(PMA)
Authoring and
updating Clinical
evaluation plan
(CEP)
Clinical Evaluation
Report
(CER) compliant
with MEDDEV 2.7.1
rev 4 guidance and
MDR 2017/745
Systematic literature
reviews (SLR)
Post marketing
surveillance (PMS)
and post marketing
clinical follow-up
(PMCF) plan
Periodic safety
update report
(PSUR)
Summary of safety
and clinical
performance (SSCP)
SOP development
11
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
QC planning
QC review
QC assessment
QC reporting
QC change
incorporation
Continuous audit of the
existing system/process
 Verify accuracy of 100% of the data presented in the document
 Ensuring consistency of appearance and adherence to an
agreed-upon style guide
 Checking for consistency of presentation, format, grammar, use of
abbreviations (and the list of abbreviations, if present), references
cited; and
 Confirming cross-references in the document are correct.
QC OF REGULATORY DOCUMENTS
13
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Scientific
communications
14
SCIENTIFIC COMMUNICATIONS
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Publication
planning, writing
and submission
Conference
support
Medical
Education
Advisory
board
meeting
15
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Publication planning
 Understand the objective of
publication
 Select target journals and
conferences/congresses
 Create an annual timeline for
activities
Manuscript writing
 Developing the manuscript for
various primary and secondary
publication according to selected
target journal
Basic editing
 Grammar and language check
 Flow and consistency
 Formatting according to journal
Substantiate editing
 Medical review
 Grammar and language check
 Plagiarism check and correction
 References check
 Flow and consistency
 Formatting according to journal
Submission
 Target journal selection
 Making journal submission
ready
 Collect and prepare all
submission related documents
 Submit the paper and follow
up with the journal on the
status of the paper
 Addressing journals comment
PUBLICATION PLANNING, WRITING AND SUBMISSION
16
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
PUBLICATION DOCUMENTS
Original Research
Narrative Review
Case reports/case seriesSystematic review and
meta-analysis
Clinical Practice Guideline
Consensus Recommendation
Position Statement | Expert Opinion
Congress support: Abstracts
Posters | Oral presentations
17
Conference Coverage
1. Conference support
for sessions
2. Content presentation
in the form of reports
Identifying conferences in
specific domain (therapeutic
area)
Contacting conference
administration
Co-ordination for registration of
HCPs on behalf of the client
Scope of Work:
 Create conference tracker
 Coverage of conference and report writing
 KOL interviews and key highlights daily
 Create abstract, poster and oral presentations
CONFERENCE SUPPORT
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
18
MEDICAL EDUCATION
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Create/update training content for HCP, MSLs, and field force
professionals
Apply for accreditation for content/training module
Suggest online CME/online accreditation courses available based
on disease area and product
Training manuals E-modules 際際滷 decks
19
Pre-meeting Meeting Post-meeting
Identify an unmet need in
a specified therapeutic
area
Prepare a pre-meeting
presentation, meeting
collaterals
Identifying KOLs and get
them onboard (if
needed)
Cover the meeting
Taking minutes of
meeting
Moderating the
session
Develop a report/MoM
Publication
Possible Outcomes from
Advisory Board:
 際際滷 sets for internal
trainings
 Expert Opinion
 Consensus
recommendation/
Guidelines/Statements
END-TO-END VIRTUAL/PHYSICAL ADVISORY BOARD SUPPORT
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
20
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Commercial
and
Marketing Solutions
21
COMMERCIAL AND MARKETING SOLUTIONS
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Product launch support
際際滷 decks
HCP engagement
(conventional and virtual)
Market analysis and KOL profiling
Website content and blogs
Infographics and videos
for HCP and patients
22
PRODUCT LAUNCH SUPPORT
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Content in designed PDF  (for HCPs,
field force and/or patients)
Digital Deliverables for
promotion/Marketing
Monograph Booklet/Book
LBL/Newsletter/
Leaflet
Rx Pads/Posters
Visual Aids
E-Newsletter Website
Video bites Infographics
Emailers
Reprints  copyright
articles for
e-circulation
E-detailers
23
SLIDE DECKS
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
際際滷-decks from original research articles to be
distributed among HCPs/KOLs
際際滷-decks for advisory board meetings
際際滷-decks for CME meetings
際際滷-decks to be presented in conferences
24
HCP ENGAGEMENT
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Virtual advisory boards/ Virtual meetings (round table/standalone)/
Webinars with top shot KOLs in domain (We will identify KOLs and get them
onboard if needed)
Ready online CMEs from reputed scientific bodies for HCPs and paramedic
staff
Virtual Conferences (we will look for conferences in their therapy and get
registration on their behalf)
Newsletters: content, designing and integrating with survey link to gather
feedback from KOLs and share monthly/report with client
Round table meetings, sharing post-meeting report
25
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
KOL/influencer Mapping & engagement
 KOL Profiling
 KOL engagement by regular
emails/newsletters/round table meetings
 Advocacy building
Market analysis
 Competitive analysis in report/ppt.
 KOL/Physicians survey
 Market research reports
Illustration of KOL Mapping
MARKET ANALYSIS AND INFLUENCER MAPPING
26
WEBSITE CONTENT AND BLOGS
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Product websites
Disease sensitization
Unbranded content for product promotion
Disease awareness content for blogs
Updating and developing content for your websites
27
INFOGRAPHICS AND VIDEOS- FOR HCP AND PATIENTS
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
Continuous engagement of KOLs and patients
through infographics and videos
Developing
content
Designing
Shared through
WhatsApp/email and
integrating with
survey link to gather
feedback from KOLs
and share monthly/
report with client
28
TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE
CLIENTELE
29
http://turacoz.com/
Turacoz Offices
Gurugram, India
Pune, India
New Jersey, US
Canada
Singapore
hello@turacoz.in
Netherlands

More Related Content

Turacoz medical writing services for medical devices

  • 2. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Turacoz is an ISO Certified 9001:2008 medical writing, training and consultancy company working with top MNCs (medical device, pharmaceutical, biotech, invitro diagnostics, consumer care, cosmetics and aesthetics) and research institutes and healthcare professionals globally. i Founded in: 2014 Founder: Dr Namrata Singh Headquarters: India Registered offices: The Netherlands, Singapore, Toronto and New Jersey Number of clients 端 Industry: 35 端 Research institutes: 82 Employees: 100+
  • 3. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT US Regulatory affairs team Scientific and Medical Team Account Managers and Project Managers Quality Check Specialist Graphic Designing and E-learning Development team TURACOZ TEAM MEDICAL DIRECTOR 04
  • 4. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT US P e r f e c t i o n P e o p l e P l a n e t 端 Robust recruitment process and skill/experience mapping 端 Continuous professional development in form of internal and external trainings 端 Can work onsite and offsite 端 Technical team available for all major time zones 端 Focus on productivity and overall efficiency 端 Work as strategic partners and not only as vendors 端 Stringent process to maintain quality and meet timelines 端 Prompt project management 端 Customized solutions based on client requirements/unmet need 端 80% is repeat business 端 Goal is to create sustainable business 端 CSR and environment friendly initiatives 端 Spread health and lifestyle awareness regularly through blogs/social media/events/partnerships 端 Women empowerment activities HAPPY TEAM ALWAYS LEADS TO HAPPY CLIENTS WHY TURACOZ 05
  • 5. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT US Regulatory affairs consulting and writing Scientific communications Medical Education SERVICE SPECTRUM 07
  • 6. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Regulatory affairs consulting and writing 08
  • 7. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Compliant with the MEDDEV and MDR. Our clinical evaluation services are based on: Currently available scientific literature Completed clinical investigations Conformity assessment to determine safety and performance of devices US, EU, INDIA, ASEAN, CANADA, LATAM Regulatory Strategy and Consultancy Technical documentation QC of regulatory documents Regulatory submission and responses REGULATORY AFFAIRS CONSULTING AND WRITING 09
  • 8. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE REGULATORY STRATEGY AND CONSULTANCY Gap analysis and compliances of region-specific regulations Pre-submission queries to regulatory agencies Regulatory submissions Responses to queries from regulatory authorities EU MDR consulting services to support transition to the new regulations 10
  • 9. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE TECHNICAL DOCUMENTATION 510(k) submission or Pre-market approval (PMA) Authoring and updating Clinical evaluation plan (CEP) Clinical Evaluation Report (CER) compliant with MEDDEV 2.7.1 rev 4 guidance and MDR 2017/745 Systematic literature reviews (SLR) Post marketing surveillance (PMS) and post marketing clinical follow-up (PMCF) plan Periodic safety update report (PSUR) Summary of safety and clinical performance (SSCP) SOP development 11
  • 10. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE QC planning QC review QC assessment QC reporting QC change incorporation Continuous audit of the existing system/process Verify accuracy of 100% of the data presented in the document Ensuring consistency of appearance and adherence to an agreed-upon style guide Checking for consistency of presentation, format, grammar, use of abbreviations (and the list of abbreviations, if present), references cited; and Confirming cross-references in the document are correct. QC OF REGULATORY DOCUMENTS 13
  • 11. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Scientific communications 14
  • 12. SCIENTIFIC COMMUNICATIONS TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Publication planning, writing and submission Conference support Medical Education Advisory board meeting 15
  • 13. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Publication planning Understand the objective of publication Select target journals and conferences/congresses Create an annual timeline for activities Manuscript writing Developing the manuscript for various primary and secondary publication according to selected target journal Basic editing Grammar and language check Flow and consistency Formatting according to journal Substantiate editing Medical review Grammar and language check Plagiarism check and correction References check Flow and consistency Formatting according to journal Submission Target journal selection Making journal submission ready Collect and prepare all submission related documents Submit the paper and follow up with the journal on the status of the paper Addressing journals comment PUBLICATION PLANNING, WRITING AND SUBMISSION 16
  • 14. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE PUBLICATION DOCUMENTS Original Research Narrative Review Case reports/case seriesSystematic review and meta-analysis Clinical Practice Guideline Consensus Recommendation Position Statement | Expert Opinion Congress support: Abstracts Posters | Oral presentations 17
  • 15. Conference Coverage 1. Conference support for sessions 2. Content presentation in the form of reports Identifying conferences in specific domain (therapeutic area) Contacting conference administration Co-ordination for registration of HCPs on behalf of the client Scope of Work: Create conference tracker Coverage of conference and report writing KOL interviews and key highlights daily Create abstract, poster and oral presentations CONFERENCE SUPPORT TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE 18
  • 16. MEDICAL EDUCATION TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Create/update training content for HCP, MSLs, and field force professionals Apply for accreditation for content/training module Suggest online CME/online accreditation courses available based on disease area and product Training manuals E-modules 際際滷 decks 19
  • 17. Pre-meeting Meeting Post-meeting Identify an unmet need in a specified therapeutic area Prepare a pre-meeting presentation, meeting collaterals Identifying KOLs and get them onboard (if needed) Cover the meeting Taking minutes of meeting Moderating the session Develop a report/MoM Publication Possible Outcomes from Advisory Board: 際際滷 sets for internal trainings Expert Opinion Consensus recommendation/ Guidelines/Statements END-TO-END VIRTUAL/PHYSICAL ADVISORY BOARD SUPPORT TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE 20
  • 18. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Commercial and Marketing Solutions 21
  • 19. COMMERCIAL AND MARKETING SOLUTIONS TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Product launch support 際際滷 decks HCP engagement (conventional and virtual) Market analysis and KOL profiling Website content and blogs Infographics and videos for HCP and patients 22
  • 20. PRODUCT LAUNCH SUPPORT TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Content in designed PDF (for HCPs, field force and/or patients) Digital Deliverables for promotion/Marketing Monograph Booklet/Book LBL/Newsletter/ Leaflet Rx Pads/Posters Visual Aids E-Newsletter Website Video bites Infographics Emailers Reprints copyright articles for e-circulation E-detailers 23
  • 21. SLIDE DECKS TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE 際際滷-decks from original research articles to be distributed among HCPs/KOLs 際際滷-decks for advisory board meetings 際際滷-decks for CME meetings 際際滷-decks to be presented in conferences 24
  • 22. HCP ENGAGEMENT TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Virtual advisory boards/ Virtual meetings (round table/standalone)/ Webinars with top shot KOLs in domain (We will identify KOLs and get them onboard if needed) Ready online CMEs from reputed scientific bodies for HCPs and paramedic staff Virtual Conferences (we will look for conferences in their therapy and get registration on their behalf) Newsletters: content, designing and integrating with survey link to gather feedback from KOLs and share monthly/report with client Round table meetings, sharing post-meeting report 25
  • 23. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE KOL/influencer Mapping & engagement KOL Profiling KOL engagement by regular emails/newsletters/round table meetings Advocacy building Market analysis Competitive analysis in report/ppt. KOL/Physicians survey Market research reports Illustration of KOL Mapping MARKET ANALYSIS AND INFLUENCER MAPPING 26
  • 24. WEBSITE CONTENT AND BLOGS TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Product websites Disease sensitization Unbranded content for product promotion Disease awareness content for blogs Updating and developing content for your websites 27
  • 25. INFOGRAPHICS AND VIDEOS- FOR HCP AND PATIENTS TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE Continuous engagement of KOLs and patients through infographics and videos Developing content Designing Shared through WhatsApp/email and integrating with survey link to gather feedback from KOLs and share monthly/ report with client 28
  • 26. TURACOZ TEAMABOUT TURACOZ WHY TURACOZ SERVICE SPECTRUM OUR CLIENTS CONTACT USTURACOZ EXPERIENCE CLIENTELE 29
  • 27. http://turacoz.com/ Turacoz Offices Gurugram, India Pune, India New Jersey, US Canada Singapore hello@turacoz.in Netherlands