U.S.
PMTA
Blackbriar Regulatory Services is the industry leader in PMTA submissions, remediations, and re-filings. We specialize not only in developing quality PMTA’s from start to finish, but also in redeveloping applications that have received Marketing Denial Orders (MDOs). If you’ve received an MDO, let our team of experts analyze your application, develop a strategic program to address missing components, and get your re-submitted PMTA to market authorization, quickly and economically.
U.S.
PMTA
Blackbriar Regulatory Services is the industry leader in PMTA submissions, remediations, and re-filings. We specialize not only in developing quality PMTA’s from start to finish, but also in redeveloping applications that have received Marketing Denial Orders (MDOs). If you’ve received an MDO, let our team of experts analyze your application, develop a strategic program to address missing components, and get your re-submitted PMTA to market authorization, quickly and economically.
PMTA RE-FILING
If you have received a Marketing Denial Order (MDO) on your original PMTA application, BRS will conduct a complete gap analysis and provide you with a strategy and proposal for conducting the missing work and resubmitting your application. In almost every case, this will include a Longitudinal Cohort Study to demonstrate the importance of flavors and various device formats, the number one reason for MDO’s issued to date.
PMTA RE-FILING
If you have received a Marketing Denial Order (MDO) on your original PMTA application, BRS will conduct a complete gap analysis and provide you with a strategy and proposal for conducting the missing work and resubmitting your application. In almost every case, this will include a Longitudinal Cohort Study to demonstrate the importance of flavors and various device formats, the number one reason for MDO’s issued to date.
LONGITUDINAL COHORT STUDIES
In mid-2021, the FDA rejected PMTA applications for millions of flavored e-liquids on the basis that these applications lack sufficient evidence demonstrating that the flavored ENDS products will provide a benefit to adult users that would be adequate to outweigh the risks to youth. The agency further recommended that the best path to obtaining such evidence was through a long-term Longitudinal Cohort study that demonstrates the benefit of the flavored ENDS products over an appropriate comparative tobacco-flavored ENDS product. BRS has teamed up with one of the world leaders in conducting such studies and jointly developed a protocol for providing this missing information in your PMTA application.
Contact BRS for joining the Longitudinal Cohort Syndicate to save money on this key study the FDA is mandating. Don’t wait, Cohort begins November 2021.
FULL PMTA DEVELOPMENT & SUBMISSION
Our robust team of experienced scientists, researchers, project managers, and regulatory specialists have been working in the regulated ENDS products industry since 2016 and have submitted applications for over 300 products to date. Through this combined experience, we’ve developed a tried-and-true process for creating and submitting your PMTA application, start to finish. Whether you are submitting an application for one product, one hundred products, or one thousand products, our team is ready to provide full-service regulatory solutions for all of your PMTA needs big and small.
LONGITUDINAL COHORT STUDIES
In mid-2021, the FDA rejected PMTA applications for millions of flavored e-liquids on the basis that these applications lack sufficient evidence demonstrating that the flavored ENDS products will provide a benefit to adult users that would be adequate to outweigh the risks to youth. The agency further recommended that the best path to obtaining such evidence was through a long-term Longitudinal Cohort study that demonstrates the benefit of the flavored ENDS products over an appropriate comparative tobacco-flavored ENDS product. BRS has teamed up with one of the world leaders in conducting such studies and jointly developed a protocol for providing this missing information in your PMTA application.
Contact BRS for joining the Longitudinal Cohort Syndicate to save money on this key study the FDA is mandating. Don’t wait, Cohort begins November 2021.
FULL PMTA DEVELOPMENT & SUBMISSION
Our robust team of experienced scientists, researchers, project managers, and regulatory specialists have been working in the regulated ENDS products industry since 2016 and have submitted applications for over 300 products to date. Through this combined experience, we’ve developed a tried-and-true process for creating and submitting your PMTA application, start to finish. Whether you are submitting an application for one product, one hundred products, or one thousand products, our team is ready to provide full-service regulatory solutions for all of your PMTA needs big and small.
INDIVIDUAL SERVICES
Our team is proud to offer a wide range of high-quality scientific services to support your product’s premarket applications for the Food and Drug Administration (FDA). If you are looking for assistance in any of the areas below, contact us today and consult with our team on how Blackbriar Regulatory Services can help you.
INDIVIDUAL SERVICES
Our team is proud to offer a wide range of high-quality scientific services to support your product’s premarket applications for the Food and Drug Administration (FDA). If you are looking for assistance in any of the areas below, contact us today and consult with our team on how Blackbriar Regulatory Services can help you.
Administrative Services
- eCTD & eTTD Formatting
- Cover Letter
- Reviewers Guide
- Integrated Summary
- Letters of Authorization
- Environmental Assessment
- Hyperlinking
Chemistry, Manufacturing, and Controls (cmc) Services
- TPMF
- Cover Letter
- Reviewers Guide
- Integrated Summary
- Letters of Authorization
- Environmental Assessment
- Hyperlinking
Clinical Services
- PK Study
- Abuse Liability
- Puff Topography
Non-Clinical Services
- HPHC Testing
- Toxicology
- Stability
- Literature Review
Perception & Intent Services
- Qualitative Study
- Quantitative Study
- Human Factor Study
- Marketing Plan Development
- Literature Review
- Label Compliance
Training Services
- Training for FDA Inspections
Administrative Services
- eCTD & eTTD Formatting
- Cover Letter
- Reviewers Guide
- Integrated Summary
- Letters of Authorization
- Environmental Assessment
- Hyperlinking
Chemistry, Manufacturing, and Controls (cmc) Services
- TPMF
- Cover Letter
- Reviewers Guide
- Integrated Summary
- Letters of Authorization
- Environmental Assessment
- Hyperlinking
Clinical Services
- PK Study
- Abuse Liability
- Puff Topography
Non-Clinical Services
- HPHC Testing
- Toxicology
- Stability
- Literature Review
Perception & Intent Services
- Qualitative Study
- Quantitative Study
- Human Factor Study
- Marketing Plan Development
- Literature Review
- Label Compliance
Training Services
- Training for FDA Inspections