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Changing the way  medicine is administered

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CONSULTANTS

Technology Partners

Joe Kerr

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.

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.

 

Legal Services

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.

Patent Attorneys

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

business strategy

Lakefield, ON

(705) 652-6100

info@pkasofttouch.com