Quality management system

HYTN Provides Corporate Update, Outlines New Global Direction

Retrieved on: 
Wednesday, April 3, 2024
Certification, Good manufacturing practice, Therapeutic Goods Administration, The Company, DAB, European Pharmacopoeia, Quality management system, GMP, Cannabis, TGA, PIC/S, Drug

HYTN is announcing two strategic commercial initiatives underscoring the company’s commitment to leading the GMP-certified cannabis products industry.

Key Points: 
  • HYTN is announcing two strategic commercial initiatives underscoring the company’s commitment to leading the GMP-certified cannabis products industry.
  • HYTN expects to commercialize both business to business and wholesale opportunities under this initiative.
  • Additionally, HYTN aims to unlock global markets for established cannabis brands by leveraging the company's regulatory compliance, supply chain capabilities and Quality Management System.
  • The authorization to process cannabis flower into pharmaceutical-grade products for export provides a significant advantage in a market actively seeking GMP-certified cannabis."

SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 11.5 MILLION IN AN EQUITY PLACEMENT

Retrieved on: 
Thursday, March 21, 2024
Cardiorenal syndrome, EUR, Partner, DSR, Offering, Liver disease, Ketel One, KBC, Patient, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, EQT, LSP, PMA, US FDA, NASH, Overload, THT, USD, FDA, Security (finance)

This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.

Key Points: 
  • This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.
  • We look forward to continuing our track record of meeting our corporate milestones and driving Sequana Medical forward."
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • As announced in February 2024, the Company entered into an unsecured and subordinated convertible loan agreement with Partners in Equity and Rosetta Capital for an aggregate principal amount of EUR 3.0 million.

Carmell Sharpens Aesthetics Focus with Execution of Definitive Agreement to Sell Axolotl Biologix Subsidiary

Retrieved on: 
Wednesday, March 20, 2024
AARP, EPS, Internet, NetSuite, Sale, Acquisition, Quality management system, Aesthetics, Education minister, Skin, Oracle, Security (finance)

In January 2024, Carmell announced the addition of several Key Opinion Leaders in the Aesthetics industry to their Scientific Advisory Board and commenced clinical product testing.

Key Points: 
  • In January 2024, Carmell announced the addition of several Key Opinion Leaders in the Aesthetics industry to their Scientific Advisory Board and commenced clinical product testing.
  • launch, Carmell plans to launch 9 other skincare products that are in advanced stages of development and slated for launch through Summer 2024.
  • $15.6 million reduction in debt: $7.6 million of AxoBio subsidiary level debt plus $8 million note payable related to the AxoBio acquisition.
  • 29% reduction in EPS dilution due to the return of 8.09 million CTCX common shares on a fully diluted basis.

SEQUANA MEDICAL LAUNCHES EQUITY PLACEMENT AND PROVIDES TRADING UPDATE

Retrieved on: 
Wednesday, March 20, 2024
EUR, Partner, Tax, DSR, Offering, Liver disease, FY, Ketel One, KBC, International, Committee, Financial services, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, FSMA, Person, European, EQT, LSP, PMA, US FDA, Overload, Stock, Marketing, Transaction, Security (finance)

(ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.

Key Points: 
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • The Offering shall be structured as a private placement of new shares via an accelerated bookbuilding, which will commence immediately.
  • Trading in Sequana Medical shares on the regulated market of Euronext Brussels will be suspended during the bookbuilding period.
  • Trading in the shares is expected to resume following the publication of the results of the Offering.

GLUCOTRACK EXPANDS LEADERSHIP TEAM WITH NEW VICE PRESIDENT OF QUALITY

Retrieved on: 
Tuesday, March 12, 2024
Transfer, Risk management, Certification, Biomedicine, Biomedical engineering, University, Diabetes, Senior management, Class, Commercial, Quality management system, Doctor of Philosophy, Process validation, Bachelor, Quality management, Sustainability, ISO, FDA

He will lead ISO-13485 certification and all related quality activities for the Company’s implantable Continuous Blood Glucose Monitoring (CBGM) technology.

Key Points: 
  • He will lead ISO-13485 certification and all related quality activities for the Company’s implantable Continuous Blood Glucose Monitoring (CBGM) technology.
  • “We are thrilled that Vincent has joined our growing team in this important leadership role.” said Paul Goode, PhD, CEO of Glucotrack.
  • Implementing a sustainable Quality Management System that will grow with us is essential as we now embark on product development activities for our commercial product.
  • I look forward to joining this leadership team to bring this differentiated technology to people with diabetes,” said Mr. Wong.

Rip Road Announces ISO 13485:2016 Certification

Retrieved on: 
Wednesday, March 27, 2024
Software, Pharmaceutical, Data Management, Apps, Applications, Medical Devices, Technology, Security, Health Technology, Biotechnology, Wearables, Mobile Technology, Alternative Medicine, Health, Certification, Organization, Patient, Sale, Medical device, Quality management system, QMS, Safety, Providers, Multimedia, ISO, Medicine

Rip Road, a leading provider of Software as a Medical Device (SaMD) companion applications for biologic medications and medication delivery devices, announced today that it has received certification of their Quality Management System (QMS) to the requirements of ISO 13485:2016.

Key Points: 
  • Rip Road, a leading provider of Software as a Medical Device (SaMD) companion applications for biologic medications and medication delivery devices, announced today that it has received certification of their Quality Management System (QMS) to the requirements of ISO 13485:2016.
  • View the full release here: https://www.businesswire.com/news/home/20240327209932/en/
    ISO 13485:2016 certification demonstrates Rip Road’s adherence to regulatory standards and commitment to safety, data security, and effective engineering processes.
  • (Graphic: Business Wire)
    Rip Road’s pharmaceutical and medical device clients build their SaMD companion applications on the highly configurable Rip Road Platform.
  • "This certification represents an important milestone for Rip Road and reflects our commitment to quality in providing best-in-class SaMD companion applications for our clients," said Eric Leven, president of Rip Road.

Kemp Proteins and Columbia Biosciences Announce Strategic Partnership for Fluorophore Conjugation Solutions

Retrieved on: 
Tuesday, April 2, 2024
Partnership, Projection screen, Research, Strategic partnership, Protein, Luminex, Antibody, Drug development, Quality management system, Therapy, Microscopy, Vaccine

FREDERICK, Md., April 2, 2024 /PRNewswire-PRWeb/ -- Kemp Proteins LLC, a leading provider of monoclonal antibody development and gene-to-protein services, announced today that the company has entered a Strategic Partnership with Columbia Biosciences of Frederick, Maryland. With a long history in manufacturing of fluorescent proteins and renowned excellence in protein conjugation, Columbia Biosciences uses its experience to select appropriate fluorophores and conjugation chemistries for target antibodies and proteins. Columbia's technology is broadly applicable in the molecular tools and diagnostic space with applications in Flow Cytometry, Luminex, Western Blot/ELISA, Microscopy and High Throughput Screening. The combination of Kemp's capability to develop and manufacture gram quantities of proteins and monoclonal antibodies for its clients, together with Columbia's superior fluorescent conjugation, will provide a streamlined opportunity to generate client-directed, custom-tailored ready-to-use molecular tools manufactured under ISO13485:2016 compliant Quality Management Systems.

Key Points: 
  • FREDERICK, Md., April 2, 2024 /PRNewswire-PRWeb/ -- Kemp Proteins LLC, a leading provider of monoclonal antibody development and gene-to-protein services, announced today that the company has entered a Strategic Partnership with Columbia Biosciences of Frederick, Maryland.
  • With a long history in manufacturing of fluorescent proteins and renowned excellence in protein conjugation, Columbia Biosciences uses its experience to select appropriate fluorophores and conjugation chemistries for target antibodies and proteins.
  • Under the Partnership, Kemp Proteins will utilize its proven monoclonal antibody development and gene-to-protein capabilities to produce, purify and QC the antibodies/proteins for supply to Columbia Biosciences for fluorescent labeling.
  • This strategic partnership will provide turnkey custom solutions for our biopharma, diagnostic and life science clients," said Michael Keefe, CEO for Kemp Proteins.

Columbia Biosciences and Kemp Proteins Enter Strategic Partnership for Fluorophore Conjugation Solutions

Retrieved on: 
Tuesday, April 2, 2024
Partnership, Research, Strategic partnership, Protein, Quality management system, Therapy, Fluorophore

FREDERICK, Md., April 2, 2024 /PRNewswire-PRWeb/ -- Columbia Biosciences Corp, a leading provider of fluorescent dyes and custom conjugation services, today announced that the company has entered a Strategic Partnership with Kemp Proteins LLC of Frederick, Maryland. This collaboration combines Kemp Proteins' antibody development and protein manufacturing services with Columbia Biosciences' expertise in protein and antibody conjugation. The combination of Kemp's ability to develop and manufacture gram quantities of proteins and monoclonal antibodies for its clients, together with Columbia's experience in custom conjugation and critical reagent development, will provide a streamlined opportunity to generate client-directed, custom-tailored ready-to-use molecular tools manufactured under ISO13485:2016 compliant Quality Management Systems.

Key Points: 
  • FREDERICK, Md., April 2, 2024 /PRNewswire-PRWeb/ -- Columbia Biosciences Corp, a leading provider of fluorescent dyes and custom conjugation services, today announced that the company has entered a Strategic Partnership with Kemp Proteins LLC of Frederick, Maryland.
  • This collaboration combines Kemp Proteins' antibody development and protein manufacturing services with Columbia Biosciences' expertise in protein and antibody conjugation.
  • Under the Partnership, Kemp Proteins will utilize its proven monoclonal antibody development and gene-to-protein capabilities to produce, purify and QC the antibodies/proteins for supply to Columbia Biosciences for fluorescent labeling.
  • John Morseman, CEO of Columbia Biosciences, echoed Keefe's sentiments: "Columbia Biosciences and Kemp Proteins can leverage their respective strengths to provide turnkey solutions for biopharma and life science clients, accelerating research and development efforts in diagnostics and therapeutics."

Carmell Announces Product Development Completed for G.L.E.E. Launch in March 2024

Retrieved on: 
Monday, February 26, 2024
Oracle, Mothercare, Photoprotection, Excipient, US FDA, Skin, Pregnancy, Safety, Foul, NetSuite, Food and Drug Administration, Protein, Quality management system, CGMP, Good manufacturing practice, Cosmetics

PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell” or the “Company”), today announced that they have completed product development of their Gold Limited Edition Exclusive (G.L.E.E.)

Key Points: 
  • PITTSBURGH, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell” or the “Company”), today announced that they have completed product development of their Gold Limited Edition Exclusive (G.L.E.E.)
  • product for commercial launch in March 2024.
  • Additionally, the Company is in advanced stages of development and testing of 9 other skincare products anticipated to launch over Spring and Summer 2024.
  • The Carmell skincare product portfolio:
    Carmell G.L.E.E.

Calibre Intercepts High Grade Gold Mineralization at the Limon Mine Complex, Proximal to the Limon Processing Plant; Drilling Intersects Include 68.72 g/t Gold Over 2.0 Metres and 18.68 g/t Gold Over 6.0 Metres

Retrieved on: 
Monday, February 26, 2024
Bureau Veritas, Veritas, CXB, ETW, News, TSX, SAS, Biophysical environment, Quality management system, QA/QC, Quality, Vein, Element, Environmental resource management, Gold, SAG, National instrument, ISO14001, National Instrument 43-101, ICP, OTCQX, Silver, Nightclub

These high-grade intercepts combined with the recent positive news from the Panteon VTEM Gold Corridor , demonstrate that the entire Limon district remains open for expansion and discovery.

Key Points: 
  • These high-grade intercepts combined with the recent positive news from the Panteon VTEM Gold Corridor , demonstrate that the entire Limon district remains open for expansion and discovery.
  • Note: Estimated True Widths for reported vein intercepts are based on 3D models of the individual veins.
  • Darren Hall, President and Chief Executive Officer of Calibre, stated: “I am excited by these exceptionally high-grade drill results from numerous targets at our Limon Gold Mine.
  • Drilling efforts have not only instilled confidence at the yet-to-be-developed Pozo Bono open pit project but have also identified underground potential along the Limon trend.