KRTL outlines how expanded regulatory leadership expects to support its developing South American API, botanical, controlled substance, and pharmaceutical strategy
Lakewood, CO, Sept. 16, 2026 (GLOBE NEWSWIRE) — KRTL Holding Group Inc. (OTC: KRTL) (“KRTL” or the “Company”) today outlined how KRTL Biotech Inc. intends to apply its expanded regulatory leadership to the Company’s developing South American pharmaceutical API, controlled-substance, botanical-drug, research, and regulatory-services strategy.
Justin Abril, KRTL Biotech’s President-Designate and Strategic Regulatory & API Consultant, https://krtlbiotech.com/team/justin-abril, brings more than a decade of experience in federal controlled-substance compliance, Schedule I manufacturing, DEA regulatory affairs, and pharmaceutical quality systems. His experience is expected to support KRTL’s developing API, controlled-substance, botanical-drug, and regulatory initiatives.
KRTL believes that developing international pharmaceutical supply relationships requires more than identifying compounds, suppliers, laboratories, or manufacturers. Prospective opportunities must be evaluated against regulatory, quality, security, documentation, analytical, manufacturing, import, and downstream-development requirements before they can be considered for a U.S. pharmaceutical pathway.
Developing a South American API Qualification Pathway
KRTL is evaluating and developing prospective South American relationships involving pharmaceutical APIs, botanical-derived materials, laboratories, technical capabilities, and manufacturing partners. These capabilities are not represented as currently qualified, licensed, or commercially API-ready for any U.S. program. KRTL intends to advance selected opportunities through technical, quality, regulatory, contractual, and commercial diligence before they are considered for U.S. pharmaceutical development or importation.
Abril will help KRTL build the regulatory and qualification framework used to evaluate prospective facilities, API manufacturers, laboratories, botanical sources, research organizations, and technical partners.
• API and CMC documentation and development readiness.
• cGMP manufacturing and pharmaceutical quality systems.
• Analytical testing, specifications, and quality controls.
• Supplier, facility, and partner qualification.
• Supply-chain integrity, traceability, and change-control expectations.
• U.S. import eligibility and appropriate importer pathways.
• DEA registration scope, controlled-substance drug codes, quotas, and import/export authority where applicable.
• Controlled-substance security, storage, recordkeeping, and inventory accountability.
• Applicable FDA, state, institutional, and foreign-country requirements.
• Qualified U.S. research, manufacturing, development, and commercialization partners.
“As we develop prospective relationships in South America, our objective is to determine which opportunities can realistically progress into compliant U.S. pharmaceutical programs,” said Cesar Herrera, Chief Executive Officer of KRTL Biotech Inc. “Justin will help us establish the regulatory, quality, and partner-qualification framework needed to evaluate those opportunities systematically.”
Supporting KRTL’s Coca-Derived Pharmaceutical and API Strategy
KRTL has developed two coca-derived extract platforms, Rayel and Periko. Company records include a TTB formula approval record for Rayel Decocainized Natural Coca Extract, providing an existing regulatory foundation for its applicable beverage-facing use. Together, the two extracts provide KRTL with multiple pathways to evaluate across commercial, analytical, formulation, API, and pharmaceutical applications.
Abril’s experience in Schedule I manufacturing, controlled-substance compliance, pharmaceutical quality systems, DEA regulatory affairs, and regulated supply chains is expected to help KRTL advance these existing assets through the appropriate regulatory and development pathways. His role is expected to include supporting qualification, quality and documentation requirements, CMC readiness, import/export planning, and identification of qualified operating and development partners.
Any coca-derived pharmaceutical or API program would remain subject to applicable DEA, FDA, state, foreign-government, customs, quality, security, and institutional requirements.
Broader Controlled-Substance and Psychedelic Research Opportunities
KRTL also intends to evaluate opportunities involving controlled botanical-drug development, pharmaceutical APIs, Schedule I research, psychedelic compounds, formulation development, analytical testing, CMC development, and institutional research collaborations.
Potential collaborators may include appropriately authorized universities, researchers, laboratories, manufacturers, CROs, clinical sites, importers/exporters, and other qualified institutions. Any such work would remain subject to the activity-specific legal and regulatory requirements applicable to the responsible operating entities.
Extending Regulatory Expertise into Third-Party Consulting Services
KRTL also expects the regulatory infrastructure being developed internally, to support the evaluation and qualification of suppliers, manufacturers, laboratories and collaborators, and, where appropriate, to support qualified third parties engaged in similar categories of pharmaceutical and controlled-substance activity that KRTL is developing. The contemplated services may include registration-readiness, facility and security planning, SOP and recordkeeping support, quota and ARCOS compliance support where applicable, import/export pathway planning, inspection readiness, supplier and facility qualification, and related cGMP and quality-system consulting.
This capability is intended to complement KRTL’s internal development programs by applying the same regulatory, quality, security, and compliance disciplines to third-party engagements. KRTL Biotech would provide advisory, readiness, documentation, and strategic support; responsibility for applications, regulated activities, and government authorizations would remain with the applicable applicant or authorized operating entity.
From Opportunity Identification to Regulatory Qualification
KRTL views Abril’s addition as part of a broader effort to strengthen the regulatory, quality, technical, institutional, manufacturing, and advisory framework used to evaluate pharmaceutical programs and support qualified third-party engagements. The Company intends to develop a repeatable diligence and qualification process that can be applied across multiple API, botanical, controlled substance, research, and consulting initiatives.
“The objective is to understand the pathway before significant resources are committed,” Herrera said. “That means identifying the regulatory requirements, qualifying the right partners, understanding the facility and quality gaps, and determining what is needed to move a viable opportunity into a legitimate development program.”
Neither Abril’s appointment nor KRTL’s current development activities should be interpreted as evidence that any South American facility, controlled-substance program, API, pharmaceutical product, DEA registration, quota, import authorization, FDA submission, or research program has received regulatory approval or is commercially operational unless specifically disclosed by the Company.
About KRTL Biotech Inc.
KRTL Biotech Inc. is a wholly owned subsidiary of KRTL Holding Group Inc. focused on pharmaceutical, biotechnology, active pharmaceutical ingredient (API), botanical, regulatory, research, and commercialization opportunities in the United States and international markets. KRTL Biotech maintains federal registrations and entity identifiers with the U.S. Food and Drug Administration and SAM.gov, including SAM.gov UEI ULPJWZWBM9L5 and CAGE Code 109P9. These registrations and identifiers support the Company’s developing pharmaceutical, regulatory, research, government-contracting, and commercialization activities and do not, by themselves, constitute FDA approval of any specific product, DEA authority, or authorization for any specific controlled-substance activity.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements regarding anticipated executive roles, pharmaceutical and API strategies, controlled substance and psychedelic research initiatives, regulatory activities, partner qualification, research collaborations, manufacturing relationships, import/export pathways, financing, commercialization, and future operations. Forward-looking statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied. There can be no assurance that contemplated regulatory registrations, permits, quotas, research approvals, import/export authorizations, manufacturing arrangements, institutional collaborations, pharmaceutical development programs, financing, or commercialization activities will be obtained or completed. Neither KRTL Holding Group Inc. nor KRTL Biotech Inc. represents that any compound, API, pharmaceutical product, manufacturing facility, research program, controlled-substance activity, DEA registration, quota, drug code, FDA submission, import authorization, or other regulated activity discussed herein has received regulatory approval unless specifically stated otherwise.
CONTACT: www.krtlholding.com info@krtlholding.com Contact: 855-KRTL-HLD www.krtlbiotech.com info@krtlbiotech.com www.krtl-icc.com info@krtl-icc.com
