Core Insights - Doseology Sciences Inc. has announced a strategic partnership with McKinney Regulatory Science Advisors to enhance its regulatory submission strategy and establish leadership in the oral pouch technology sector [1][2] Group 1: Partnership Overview - The collaboration aims to transition Doseology towards regulatory execution and commercial readiness, with McKinney providing guidance on formulation strategy, data generation, PMTA preparation, and post-market compliance [2][3] - This partnership emphasizes Doseology's commitment to scientific leadership and consumer safety in the oral pouch category [3] Group 2: McKinney's Role and Contributions - McKinney will expedite Doseology's navigation of FDA requirements, aiming to streamline development timelines and reduce regulatory uncertainty [6] - The partnership will enhance Doseology's intellectual property by aligning formulation and testing strategies with regulatory standards, ensuring dose consistency and delivery performance [6] - McKinney will assist in comprehensive PMTA readiness, covering both nicotine and innovative nicotine-analogue formulations [6] Group 3: Commitment to Safety and Compliance - The collaboration underscores Doseology's commitment to developing safe and effective products, with McKinney's expertise guiding the prioritization of necessary studies and documentation [6] - McKinney will conduct a regulatory landscape assessment for various pouch formats and define specific data and testing requirements to support anticipated claims and submissions [6]

Group 1 - Shenyang Pharmaceutical University has been approved as a "National Medical Products Administration Regulatory Science Innovation Research Base (Chemical Drug Field)," marking its entry into the national strategic echelon in the field of chemical drug regulatory science [1] - The National Medical Products Administration has approved a total of 29 regulatory science innovation research bases across various fields, including traditional Chinese medicine, chemical drugs, biological products, medical devices, cosmetics, and common research [1] - The university will collaborate with the Liaoning Provincial Inspection and Testing Certification Center and the Heilongjiang Provincial Drug Inspection Research Institute to integrate testing and inspection technology resources and establish a cross-regional research collaboration mechanism [1] Group 2 - The base will focus on quality control, change management, and intelligent regulatory technologies for chronic disease treatment drugs and complex formulations, as well as quality control technologies and dependency evaluations for narcotic and psychotropic drugs [2] - By establishing a regulatory science innovation research platform for chronic diseases, narcotic drugs, and psychotropic drugs, the base aims to promote innovation in regulatory tools, standards, and methods throughout the lifecycle of chemical drugs [2] - The base will align with the actual regulatory needs of China's chemical drugs, benchmark against international regulatory science developments, and rely on a "government-industry-university-research-application" collaborative mechanism to create a comprehensive innovation system from theoretical research to technology transfer, policy support, and talent cultivation [2]

As filed with the U.S. Securities and Exchange Commission on January 19, 2024 Registration No. 333-276308 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 45-1539785 (I.R.S. Employer Id ...

As filed with the U.S. Securities and Exchange Commission on December 29, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Processa Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 45-1539785 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 738 ...