New Current, Matt Higginson, Peterborough, ON
Matt Higginson is a talented research and development engineer who has improved our device to a highly reliable functional level. Matt has designed the device for easy transfer of 3D technology to high speed mould technology.
Joe Kerr Designs, London, ON
Joe Kerr is an innovative medical device design company and who has completed the market version device (Generation V) and the required regulatory documentation.
Steelworks Design, Peterborough, ON
Steelworks has been working with PKA SoftTouch Corp. for a number of years. Projects include the bubble design and filling station equipment which involved the purchase and modification of a Laminar Flow Hood to achieve ISO 5 sterile standards.
Merit Precision Moulding, Peterborough, ON
Merit worked on device design and production for early prototypes. Once the market version device has been completed, Merit will design the production moulds and manufacture the device parts.
Westmount Pharmacy, Peterborough, ON
The ISO 7 Sterile Suite located at Westmount serves as PKA’s pilot plant production facility. Westmount has the capability of filling and assembling devices for proof of concept clinical trials, and production runs. For clinical trials and for small markets, upgrading of this facility will be required for compliance with Health Canada and U.S. FDA regulations for U.S. human trials and production purposes.
Steris Isomedix, Whitby, ON
The ability to ensure that the PKA Micro-Needle is safe for use on humans is critical to our success. The device must undergo thorough sterilization: the appropriate sterilization method for the device is Gamma Irradiation. Steris has extensive experience with sterilization of single-use medical devices, pharmaceutical products, tissue/ biological products, and other related consumer products. Gamma irradiation ensures 100% sterile device parts.
Nordion, Laval QE
Nordion, located in Laval, Quebec, also has extensive experience with sterilization of single use medical devices. Additionally, their sister company offers sterility testing to ensure our device is 100% sterile and ready for consumer use.
James Tudhope, B.A., J.D.
Corporate & Securities Law, “Inclusive Advisory”
James Tudhope assumed responsibility for PKA’s corporate legal work in 2019. He practices corporate and securities law. “Inclusive Advisory’s” unique business model is comprehensive in that they include many different kinds of professional services. The company includes accounting, law, and wealth, and will be an asset on the upcoming equity crowdfunding campaign.
David Wires, LL.M.
Legal Counsel, Wires Jolley LLP
David Wires began his relationship with PKA SoftTouch Corp. as corporate lawyer and continues on in an advisory capacity. A specialist in litigation and arbitration law, he has served as a panelist on the China International Trade and Arbitration Commission in Beijing and as a member of the Ontario Financial Services Tribunal.
James Gastle, P.Eng., Gastle & Co.
Jim Gastle is a registered Patent Agent in both Canada and the U.S., and has developed and marketed two proprietary product lines, one of which relates to the animal health industry. Jim is a Professional Engineer, Mechanical Engineering, and a member of the Intellectual Property Institute of Canada.
Peter Milne, LL.B., Gowling Lafleur Henderson LLP
Peter Milne is also a Professional Engineer, Ceramic and Metallurgical Engineering, in addition to his law degree. A member of the Intellectual Property Institute of Canada, he previously chaired the Toronto Patent and Trademark Informal Group.aluable.
Regulatory and Quality Assurance
McCarthy Consultant Services Inc. (MCS)
McCarthy is a leader in regulatory management with expertise in the pharmaceutical, biotechnology, medical device, food, natural health and cosmetic industries. Experienced with the regulatory processes in Canada, the United States and the E.U., McCarthy provides guidance as we move towards ISO 13485 certification.
Alan Coley, B.Sc. Pharmacy
Quality & Regulatory Consultant, (MCS)
A respected consultant in Regulatory/Quality Assurance in the pharmaceutical, medical device and biotechnology industries, Alan Coley is overseeing these aspects of the business. This includes identification of equipment suitable for use in a pharmaceutical setting, regulatory processes and approvals. His experience with obtaining government approval of clinical trials is valuable.