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Joe Kerr Design: London, Ontario
Joe Kerr Design provides design and engineering services to early stage medical device companies. Joe previously started his own device company, and has worked in the medical imaging as well as surgical tools fields. Joe Kerr Design has completed the market version or the Generation IV Micro-Needle device for PKA SoftTouch. He also completed the required design regulatory documentation. The device is an advanced version of the Generation III.
Steelworks Design: Peterborough, Ontario
Steelworks, who has been working with PKA SoftTouch for a number of years is a trusted partner to world-class manufacturers in the nuclear, pharmaceutical, food and beverage, automotive and general industries. The company has designed and manufactured equipment for the drug component of the Micro-Needle.
Merit Precision Moulding: Peterborough, Ontario
MERIT provides full thermo plastic injection moulding services at its modern 50,000 Ft² facility located in Peterborough, Ontario. Merit covers several industries including: Automotive, Electronics, Packaging, Construction, and Consumer Products. Merit worked on device design and production for early Micro-Needle prototypes. Merit will design the final production moulds and manufacture the device parts for clinical trials and small production runs.
Westmount Pharmacy: Peterborough, Ontario
The ISO 7 sterile suite located at Westmount serves as PKA's clinical production facility. Wesmount is a compounding pharmacy certified to Ontario 797 sterile regulations. Westmount has the capabilities of filling and assembling devices for proof of concept trials, clinical trials, and small production runs.
Greater Peterborough Innovation Cluster (GPIC): Peterborough, Ontario
The Greater Peterborough Innovation Cluster's mission is to drive 21st century technology-based, innovation entrepreneurship-led economic growth, and high-tech job creation by supporting innovation, entrepreneurship, commercialization and new company formation & growth. PKA was an early member of GPIC's organization. GPIC continues to support PKA's technology as we move forward to commercialization.
Regulatory and Quality Assurance
David McCarthy, President/CEO
McCarthy Consultant Services Inc.: New Market, Ontario
McCarthy is a leader in regulatory affairs / quality assurance with expertise in the pharmaceutical, biotechnology, medical device, food, natural health and cosmetic industries. Experienced with the regulatory process in Canada, the United States and the U.K., his company provides PKA SoftTouch with guidance as we move towards ISO 13485 certification, a US FDA and Health Canada manufacturing requirement.
Alan Coley, B.Sc. Pharmacy
Coley Consulting Inc., Oshawa, Ontario
A respected consultant in regulatory/quality assurance in the pharmaceutical, medical device and biotechnology industries, Alan is overseeing these aspects for PKA SoftTouch. This includes identification of equipment suitable for use in a pharmaceutical facility, and regulatory processes and approvals.
John Wires, B.A., J.D.
Corporate Lawyer, Wires Law: Toronto, Ontario
John assumed responsibility for PKA's corporate legal work in 2013. He practises corporate and commercial law with a focus on high tech start-ups. Wires Law is a Toronto-based business law firm delivering legal services to entrepreneurs and small and medium- sized businesses across Canada.
James Gastle, P.Eng.
Gastle & Co.: Lakefield, Ontario
James (Jim) Gastle, a registered Patent Agent in both Canada and the United States, graduated from Mechanical Engineering at Queen's University in 1984 and began a five-year internship in a patent agency, including one year at the IP department of a Canadian forest products company and four years at a major downtown Toronto patent firm. Jim is a professional engineer, mechanical engineer and a member of the Intellectual Property Institute of Canada. Gastle & Co. looks after most of PKA's patents.
Peter Milne, LL.B.
Gowling Lafleur Henderson LLP
In addition to holding his law degree, Peter Milne is a professional engineer, specializing in ceramic and metallurgical engineering. Gowlings did the original development and filing of all our patents and now pursues the remaining patents to be approved.
SAFE, SIMPLE & PAIN FREE
THE PKA MICRO-NEEDLE REPLACES THE SYRINGE WITH A PAINLESS INTERDERMAL DELIVERY SYSTEM