Innomar Strategies buys pharma and healthcare regulatory consultancy TPIreg
Innomar Strategies, a Canadian specialty pharmaceuticals service provider, has acquired Hamilton-based boutique consultancy Therapeutic Products (TPIreg). TPIreg specializes in regulatory and quality assurance services for pharma and healthcare industry clients in North America.
From treating the common cold, to malaria and everything in between, people look to drugs to preserve and improve their health. And new drugs are a big business, with the pharmaceutical industry investing about US$12.6 billion into new drug development annually. But before a doctor or hospital can prescribe them, new drugs have to go through extensive testing and regulatory requirements, the intensity of which can depend on the jurisdiction to which the new drug is being marketed.
In the US, drugs take an average of 12 years and $350 million to make it from the lab to pharmacy shelves. After first undergoing years of lab testing and proving the new drug works on animals to the FDA, the drug will enter three phases of human clinical trials – proving the drug’s safety and efficacy. After successful clinical results, the drug will be submitted to the FDA for review: in the US, the review process takes an average of 322 days; 366 days in Europe; and 393 days in Canada.
Getting through the regulatory process surrounding pharmaceutical regulation can be a long, complex, and expensive affair. As such, some companies will turn to specialist consultancies for support in the regulatory process. One such firm is Therapeutics Products Inc. (TPIreg), a boutique consultancy founded in 2013 and based out of Hamilton, ON. TPIreg provides regulatory consulting services to the North American pharmaceutical, biotechnology, medical device, natural health products, and cosmetic industries – supporting business of all sizes in developing a regulatory strategy that helps moves products to market quicker and more successfully.
On May 3, Innomar Strategies – a leading specialty pharmaceuticals service provider in Canada – announced that it has acquired TPIreg. With the acquisition, Oakville-based Innomar – a part of drug wholesaling giant AmerisourceBergen – becomes the first full service distributor and support services company in the Canadian specialty healthcare market offering a full suite of commercialization services. Innomar helps its clients bring products to market with its commercialization services – including market access, patient support programs, clinic services, and pharmacy and logistics management. With the addition of TPIreg, Innomar adds regulatory consulting to its comprehensive service suite.
“At Innomar Strategies, we are committed to advancing the commercialization of specialty pharmaceuticals and delivering value to our patients and partners across the Canadian healthcare system,” said Innomar Strategies President Guy Payette. “TPIreg is dedicated to this same mission and we believe that together, our best-in-class combination of resources, solutions and expertise allows us to offer customers a true integration of commercialization services, including supporting full market authorization into Canada.”
TPIreg founder Anne Tomalin – a leading expert in Canadian pharmaceuticals regulation – will join Innomar, along with her team of skilled consultants. They will support Innomar in the areas of regulatory marketing and clinical trial applications, quality assurance, drug establishment licensing (DEL), and post-marketing regulatory activities. Tomalin brings over 25 years of industry experience to Innomar, as well as strong relationships with Canadian regulators.
“TPIreg will benefit from Innomar’s broad expertise and looks forward to contributing to a suite of commercialization services for companies wanting to enter the pharmaceutical market in Canada,” said Tomalin. “We are excited to join Innomar and accelerate our pace of innovation.”
