Our Flagship
Teams

At Dovank, we pride ourselves on the quality of leadership provided by our professionals. Our consultants have decades of market experience and have led many of our clients successfully through their trials. Our staff has vast experience in the specialized areas of Medical Devices, Nutraceuticals and Consumer Health so be rest assured that we will bring significant industry knowledge to your next project. Please see below how our flagship teams can support your next trial with their relevant expertise.
  • Medical Device Team
  • Nutraceutical Team
  • Consumer Health Team
  • Medical & Regulatory Writing Team
  • Medical Monitoring Team
02

Nutraceutical
Team

We understand the challenges for nutraceutical studies which are unique and complex like intense competition, precise regulatory requirements, budget constraints, resource crunch, harder to convince patients to join trials, higher dropout rates, etc. These challenges can be managed with a well-planned and effective trial design. Dovank offers a full spectrum of clinical trial services that span across planning through conduct to submissions. Catering to the worldwide evolving nutraceutical market needs, Dovank’s global capabilities span across the following:
  • Food or Color Additive Petitions
  • Nutrition Labelling & Packaging
  • Dietary Supplement Labelling
  • Regulatory Consultation
  • Post-Marketing Surveillance
  • Publishing
  • Health Claims
  • DSHEA and FDA Submissions
  • Data Management
  • Biostatistics and SAS Analysis
  • Medical & Regulatory Writing
  • Health Authority Interaction
  • Adverse Events Reporting
  • Life Cycle Management and Post-Approval Activities
Dovank assures each study is conducted in compliance with the protocol and various respective regulatory authorities worldwide such as US FDA-CFSAN, DSHEA, EFSA, Directive 2002/46/EC, FD&C Act, FSSAI, UK-MHRA, TGA, CDSCO, HEALTH CANADA, ANVISA, EMEA, SFDA, MEDSAFE, MHLW, SWISSMEDIC, KFDA, MoH, 21 CFR, etc.
04

Medical &
Regulatory Writing Team

Our medical and regulatory team can support your submissions with efficient and accurate writing skills that meet the latest regulatory requirements.  With a deep level of understanding of the requirement of each document submission, we can add superior level of quality to your documents. Our writers have extensive industry experience and therapeutic area expertise and are encouraged to enhance their technical skills by continuous medical education and trainings.
Our medical and regulatory writing services include:
  • Clinical Trial Protocol development for Phase I to IV study
  • IB, ICF and ICD
  • CSR’s  
  • ISS & ISE reports
  • Manuscript & Abstract writing
  • Slide Presentations (Original Research/Symposia/Round Table/Advisory Boards)
  • PSUR & DSUR
  • Dossiers in CTD, eCTD & ACTD Formats
  • Safety narratives
01

Medical
Device Team

Medical devices and diagnostics is a complex area and our team deeply understands the challenges that can come along the way in bringing your invention successfully to the market. We have dedicated teams specialized in Biometrics, Medical & Regulatory writing and FTE services focused to medical device industry. They are trained in 21 CFR, EMEA, GCP, ISO-14155 and stay up-to-date on the latest medical device regulations.
Dovank’s services and personnel comply by highest quality and regulatory standards for applications across all Medical Device classes. We have prepared numerous regulatory submissions and our niche services include:
  • Device Registration & Listing,
  • 510(k),
  • PMA (Premarket Approval),
  • Investigational Device Exemption (IDE),
  • Clinical Evaluation Report (CER),
  • Labeling Requirements,
  • Medical Device Reporting (MDR)
  • CE Mark certifications and Labelling
  • 21 CFR Part 11 Validation
  • Quality Engineering
  • Post Marketing Clinical Follow-up plans (PMCF) plans
  • Medical Device Labelling and Review
  • Guidance for Implementation of Unique Device Identification (UDI)
  • Health agency liaising
  • Process Validation
Our team has extensive experience preparing regulatory submission documents for Medical Devices in compliance with FDA, EU-MDR, UK MHRA, EMEA, ANVISA, TGA, CDSCO, DCGI, CDRH, office of OIVD and other global health authorities.
03

Consumer
Health Team

Dovank has extensive experience of handling Consumer Health product trials. Our dedicated team understands the unique challenges of these trials such as expedited timely delivery of bringing the product to the shelf, volunteer recruitment and ensuring robust clinical data. Our teams have innate skills to streamline the claims studies across the consumer health line of products and to generate high quality data that companies can use for their product innovation to market launch.
Dovank understands the unique needs of this industry and has a broad range of specialized resources for following services such as:
  • Protocol Development
  • Ethics Submissions
  • Trial management
  • Data Management
  • Statistical Analyses
  • Report writing
  • Geo-specific Regulatory overview
  • Health, Nutrition and Cosmetic Claims
  • Clinical study requirements
  • GxP requirements
  • Import regulations
  • Local agent requirement
  • 24-hour claim substantiation
  • Post-marketing authorization
We have expertise across consumer health areas such as hair care, skin care, cosmetic, feminine, personal and hygiene, pediatric products, OTC medications, nutritional, oral care, incontinence, etc. We comply by guidelines of CFR, FDA, Consumer Product Safety Commission, European Cosmetic, Toiletry and Perfumery Association (COLIPA), Federal Food, Drugs and Cosmetic act (FD&C) for clinical research services of Consumer Health products.
05

Medical
Monitoring Team

Our highly experienced Medical Monitors and SME’s consists of MD’s with over 10 years of experience in medical monitoring and overseeing the entire clinical trial services, from initial study design through the final study close-out ensuring the clinical integrity of the subjects, data and provide safety accountability across the duration of the study.

Our Medical Monitoring team can provide below services:

Medical
Consultation

Reviewing and Evaluating Event Collection and Reporting, Data Analysis, Clinical Study Reports (CSRs), and Regulatory Submissions

Product
safety

Processing Serious Adverse Event Reports including evaluation of relatedness and analysis of similar events for expedited cases, identifying and evaluating Safety Signals, Trends, and Events

Site
education

Training study teams on disease states, treatments, protocol compliance, inclusion and exclusion criteria, procedures, and assessments

Dovank’s medical experts have monitored trials across all major therapeutic areas and bring unparalleled industry experience to the research team.

Our Flagship
Team

At Dovank, we pride ourselves on the quality of leadership provided by our professionals. Our consultants have decades of market experience and have led many of our clients successfully through their trials. Our staff has vast experience in the specialized areas of Medical Devices, Nutraceuticals and Consumer Health so be rest assured that we will bring significant industry knowledge to your next project. Please see below how our flagship teams can support your next trial with their relevant expertise.
  • Medical Device Team
  • Nutraceutical Team
  • Consumer Health Team
  • Medical & Regulatory Writing Team
  • Medical Monitoring Team
01

Medical Device Team

Medical devices and diagnostics is a complex area and our team deeply understands the challenges that can come along the way in bringing your invention successfully to the market. We have dedicated teams specialized in Biometrics, Medical & Regulatory writing and FTE services focused to medical device industry. They are trained in 21 CFR, EMEA, GCP, ISO-14155 and stay up-to-date on the latest medical device regulations.
Dovank’s services and personnel comply by highest quality and regulatory standards for applications across all Medical Device classes. We have prepared numerous regulatory submissions and our niche services include
  • Device Registration & Listing,
  • 510(k),
  • PMA (Premarket Approval),
  • Investigational Device Exemption (IDE),
  • Clinical Evaluation Report (CER),
  • Labeling Requirements,
  • Medical Device Reporting (MDR)
  • CE Mark certifications and Labelling
  • 21 CFR Part 11 Validation
  • Quality Engineering
  • Post Marketing Clinical Follow-up plans (PMCF) plans
  • Medical Device Labelling and Review
  • Guidance for Implementation of Unique Device Identification (UDI)
  • Health agency liaising
  • Process Validation
Our team has extensive experience preparing regulatory submission documents for Medical Devices in compliance with FDA, EU-MDR, UK MHRA, EMEA, ANVISA, TGA, CDSCO, DCGI, CDRH, office of OIVD and other global health authorities.
02

Nutraceutical Team

We understand the challenges for nutraceutical studies which are unique and complex like intense competition, precise regulatory requirements, budget constraints, resource crunch, harder to convince patients to join trials, higher dropout rates, etc. These challenges can be managed with a well-planned and effective trial design. Dovank offers a full spectrum of clinical trial services that span across planning through conduct to submissions. Catering to the worldwide evolving nutraceutical market needs, Dovank’s global capabilities span across the following:
  • Food or Color Additive Petitions
  • Nutrition Labelling & Packaging
  • Dietary Supplement Labelling
  • Regulatory Consultation
  • Post-Marketing Surveillance
  • Publishing
  • Health Claims
  • DSHEA and FDA Submissions
  • Data Management
  • Biostatistics and SAS Analysis
  • Medical & Regulatory Writing
  • Health Authority Interaction
  • Adverse Events Reporting
  • Life Cycle Management and Post-Approval Activities
Dovank assures each study is conducted in compliance with the protocol and various respective regulatory authorities worldwide such as US FDA-CFSAN, DSHEA, EFSA, Directive 2002/46/EC, FD&C Act, FSSAI, UK-MHRA, TGA, CDSCO, HEALTH CANADA, ANVISA, EMEA, SFDA, MEDSAFE, MHLW, SWISSMEDIC, KFDA, MoH, 21 CFR, etc.
03

Consumer Health Team

Dovank has extensive experience of handling Consumer Health product trials. Our dedicated team understands the unique challenges of these trials such as expedited timely delivery of bringing the product to the shelf, volunteer recruitment and ensuring robust clinical data. Our teams have innate skills to streamline the claims studies across the consumer health line of products and to generate high quality data that companies can use for their product innovation to market launch.
Dovank understands the unique needs of this industry and has a broad range of specialized resources for following services such as:
  • Protocol Development
  • Ethics Submissions
  • Trial management
  • Data Management
  • Statistical Analyses
  • Report writing
  • Geo-specific Regulatory overview
  • Health, Nutrition and Cosmetic Claims
  • Clinical study requirements
  • GxP requirements
  • Import regulations
  • Local agent requirement
  • 24-hour claim substantiation
  • Post-marketing authorization
We have expertise across consumer health areas such as hair care, skin care, cosmetic, feminine, personal and hygiene, pediatric products, OTC medications, nutritional, oral care, incontinence, etc. We comply by guidelines of CFR, FDA, Consumer Product Safety Commission, European Cosmetic, Toiletry and Perfumery Association (COLIPA), Federal Food, Drugs and Cosmetic act (FD&C) for clinical research services of Consumer Health products.
04

Medical & Regulatory Writing Team

Our medical and regulatory team can support your submissions with efficient and accurate writing skills that meet the latest regulatory requirements. With a deep level of understanding of the requirement of each document submission, we can add superior level of quality to your documents. Our writers have extensive industry experience and therapeutic area expertise and are encouraged to enhance their technical skills by continuous medical education and trainings.
Our medical and regulatory writing services include:
  • Clinical Trial Protocol development for Phase I to IV study
  • IB, ICF and ICD
  • CSR’s  
  • ISS & ISE reports
  • Manuscript & Abstract writing
  • Slide Presentations (Original Research/Symposia/Round Table/Advisory Boards)
  • PSUR & DSUR
  • Dossiers in CTD, eCTD & ACTD Formats
  • Safety narratives
05

Medical Monitoring Team

Our highly experienced Medical Monitors and SME’s consists of MD’s with over 10 years of experience in medical monitoring and overseeing the entire clinical trial services, from initial study design through the final study close-out ensuring the clinical integrity of the subjects, data and provide safety accountability across the duration of the study.

Our Medical Monitoring team can provide below services:

Medical Consultation

Reviewing and Evaluating Event Collection and Reporting, Data Analysis, Clinical Study Reports (CSRs), and Regulatory Submissions

Product safety

Processing Serious Adverse Event Reports including evaluation of relatedness and analysis of similar events for expedited cases, identifying and evaluating Safety Signals, Trends, and Events

Site education

Training study teams on disease states, treatments, protocol compliance, inclusion and exclusion criteria, procedures, and assessments

Dovank’s medical experts have monitored trials across all major therapeutic areas and bring unparalleled industry experience to the research team.