Product
Se•d8™ is an orally dissolving, rapidly systemically absorbed, all-synthetic, natural single isomer CBD. The CBD wafers are individually blister packaged as designed to quickly dissolve on top of the tongue (super-lingual) to facilitate direct transmucosal absorption via the epithelial lining of the oral pharynx.
The drug manufacturing process is tightly integrated with multiple DMF/CMC documentation performed by contracted certified manufacturing organizations. Certificates of Analysis (COA) are obtained at multiple stages of the manufacturing process to document the absence of any contamination.
Multi-stage product analysis is performed by two alternating, independent, certified GLP (Good Laboratory Practices) laboratories in separate states for cross validation. All drug substance processing and drug product manufacturing are performed by two exclusively contracted cGMP certified manufacturing organizations (CMOs).
JOS Pharmaceuticals, founded and operated by a licensed physician, is dedicated to using state-of-the-art bioscience to processing and packaging of our CBD product at FDA pharmaceutical levels for new botanical drug certification. Pharmaceutical level processing and manufacturing documentation is robust with cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices) and GCP (Good Clinical Practice) and compliance with SOP (Standard Operating Procedures) QMS confirmation throughout all stages of production and study. Additional GMO and GLP standards include ISO9001:2017 as well as applicable ICH and USP designations all for our QMS (Quality Management Systems). Drug Master Files (DMF) are archived with extensively documented CMC (Chemistry, Manufacturing and Controls) verification throughout all stages consistent with USP requirements.
Certificates of Analysis
JOS Pharmaceuticals, founded and operated by a board certified anesthesiologist.
Certificates of Analysis
The drug manufacturing process is tightly integrated from our DNA genome profiled hemp seed to the multi-layered, child resistant and tamper evident, sealed final product. Certificates of Analysis (COA) are obtained at multiple stages of the harvest and manufacturing process to document the absence of any contamination from organic solvents, pesticides, heavy metals and microbials.
JOS Pharmaceuticals, founded and operated by a board certified anesthesiologist.
Multi-stage product analysis is performed by two alternating, independent, certified GLP (Good Laboratory Practices) laboratories in separate states for cross validation. All drug substance processing and drug product manufacturing are performed by two exclusively contracted cGMP certified manufacturing organizations (CMOs).
JOS Pharmaceuticals, founded and operated by a licensed physician, is dedicated to using state-of-the-art science from agriculture to processing to packaging of our CBD product at FDA pharmaceutical levels for new botanical drug certification. Pharmaceutical level processing and manufacturing documentation is robust with cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), GCP (Good Clinical Practice) and GACP certifications and compliance with SOP (Standard Operating Procedures) QMS confirmation throughout all stages of production and study. Additional GMO and GLP standards include ISO9001:2015 as well as applicable ICH and USP designations all for our QMS (Quality Management Systems). Drug Master Files (DMF) are archived with extensively documented CMC (Chemistry, Manufacturing and Controls) verification throughout all stages consistent with FDA pharma requirements.
