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Doseology Sciences Inc. (CSE: MOOD) (PINK: DOSEF) (FSE: VU70) ("Doseology" or the "Company") a leader in biotechnology-driven consumer products, today announced a strategic partnership with McKinney Regulatory Science Advisors ("McKinney"), a premier FDA regulatory consulting firm specializing in nicotine and reduced-risk consumer products, to spearhead its regulatory submission strategy and solidify its commitment to scientific leadership in the oral pouch technology space.
This collaboration marks a pivotal advancement for Doseology, transitioning the Company towards regulatory execution and commercial readiness. McKinney's comprehensive guidance will encompass formulation strategy, data generation, Pre-market Tobacco Product Application ("PMTA") preparation, and post-market compliance. The aim is to position Doseology as a frontrunner in delivering differentiated, IP and/or trade secret protected oral pouch products to regulated markets with confidence.
"Doseology is committed to leading with science and innovation in the oral pouch category. Engaging McKinney, a leader in regulatory science, ensures that our product development is not only innovative but also strategically aligned with regulatory expectations," said Tim Corkum, President & COO of Doseology. "This partnership underscores our dedication to building a defensible, regulatory-ready platform that prioritizes dose consistency and consumer safety."
"At McKinney Regulatory Science Advisors, we value working with organizations that apply a rigorous, science-based approach to product development and evaluation. Doseology's team has demonstrated a strong understanding of the role of regulatory science in identifying, characterizing, and managing product risks. We look forward to a collaborative partnership that will support the advancement of Doseology's product portfolio," said Dr. Willie McKinney, CEO of McKinney Regulatory Science Advisors.
Key Highlights of the Partnership:
- Accelerated Regulatory Pathway: McKinney's expertise is expected to expedite Doseology's navigation of FDA requirements, with the objective of streamlining development timelines and reducing regulatory uncertainty.
- Enhanced Product Design & IP Protection: The collaboration is expected to strengthen Doseology's intellectual property by aligning formulation and testing strategies with regulatory standards, ensuring dose consistency, delivery performance, and stability.
- Comprehensive PMTA Readiness: McKinney will provide structured preparation for PMTA submissions, covering both nicotine and innovative nicotine-analogue formulations.
- Integrated R&D and Manufacturing: McKinney will integrate its regulatory roadmap into Doseology's R&D program and manufacturing validation plans, ensuring formulation objectives, analytical testing, and quality systems align with regulatory expectations from the outset.
- Commitment to Consumer Safety: This partnership underscores Doseology's commitment to developing safe, effective, and transparently supported products, with McKinney's counsel helping prioritize the right studies and documentation.
McKinney's Scope of Engagement:
As part of the engagement, McKinney has agreed to:
- Conduct a regulatory landscape assessment for stimulant, nicotine, and nicotine-alternative pouch formats across relevant jurisdictions.
- Define specific data and testing requirements to support anticipated claims and submissions.
- Advise on labelling, claims language, and packaging compliance.
- Develop a pre-submission engagement plan with regulators and draft submission materials.
- Recommend a post-market surveillance framework and adverse event reporting processes.
About McKinney Regulatory Science Advisors, LLC (McKinney RSA)
McKinney Regulatory Science Advisors, LLC (McKinney RSA) is a regulatory science consulting firm providing strategic guidance on scientific testing and regulatory pathways for consumer products. The firm supports companies across the entire product lifecycle, from early development and regulatory assessment through post-market compliance.
About Doseology Sciences Inc. (CSE: MOOD | PINK: DOSEF | FSE: VU70)
Doseology Sciences Inc. is a biotechnology-driven consumer products company developing IP-backed oral stimulant technologies designed for cleaner profiles, precise delivery, and performance-focused functionality. Anchored by a commitment to rigorous scientific research and advanced formulation technologies, Doseology is dedicated to leading the industry in creating breakthrough oral stimulant products with meaningful consumer benefits. Doseology is focused on building long-term enterprise value through innovation, regulatory alignment, and the commercialization of differentiated stimulant products.
On behalf of the Board of Directors, Chris Jackson
CEO, Director
Doseology Sciences Inc.
For more information, please contact the Company at:
Email: hello@doseology.com
Website: www.doseology.com
Phone: 604.908.3095
Forward Looking Statements
This press release contains statements that constitute "forward‐looking information" within the meaning of applicable securities laws. Forward‐looking information is often identified by the words "may," "would," "could," "should," "will," "intend," "plan," "anticipate," "believe," "estimate," "expect" or similar expressions. Readers are cautioned that forward‐looking information is not based on historical facts but instead reflects the Company's management's expectations, estimates or projections concerning the business of the Company's future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. Although the Company believes that the expectations reflected in such forward‐looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance, or achievements. Among the key factors that could cause actual results to differ materially from those projected in the forward‐looking information are the following: changes in general economic, business and political conditions, including changes in the financial markets; decreases in the prevailing prices for products in the markets that the Company operates in; adverse changes in applicable laws or adverse changes in the application or enforcement of current laws; regulations and enforcement priorities of governmental authorities; and compliance with government regulation and related costs.. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward‐looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated, or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update this forward‐looking information except as otherwise required by applicable law. For more information, investors should review the Company's filings which are available on SEDAR+.
No securities regulatory authority has either approved or disapproved of the contents of this press release.
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SOURCE Doseology Sciences Inc.
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