“SPharm truly are Canada’s Drug Regulatory Experts! An exceptional team, lean and efficient with 100% understanding of Health Canada.”
VAL-D'OR, Quebec (PRWEB) December 05, 2022
SPharm Inc., one of Canada’s top health products regulatory affairs consulting firms, proudly celebrates 25 years of Regulatory Affairs excellence. The company opened its doors in 1997 when founder and CEO, Susanne Picard, started a solo practice that quickly grew in response to client demand.
SPharm is considered a key provider of regulatory intelligence services to clients in both Canada and around the globe, in a broad range of therapeutic areas. “As we celebrate our 25th anniversary this year, our hearts are filled with gratitude for the exceptional relationships we have with clients, partners, and regulatory authorities,” says Picard. “Building an award-winning practice demonstrates that we consistently honour our commitment to our clients, which is the heart of this business.”
SPharm has been trusted to efficiently manage challenging submissions, including those of ground-breaking health products for rare and ultra-rare diseases. They were among the first to implement eCTD submissions for Clinical Trial Applications (CTAs) in Canada and they manage all eCTD submission types both in Canada and globally.
“SPharm truly are Canada’s Drug Regulatory Experts! An exceptional team, lean and efficient with 100% understanding of Health Canada. They are the perfect partner in their field, seamless, proactive, prompt! We’ve worked with them for over 20 years and when I meet with sponsors, I openly recommend SPharm for any regulatory needs in our region.” Julie Martin, CEO & Co-Owner, Scimega.
They have recently reached over 100 CTAs/CTA-Amendments submissions in a single year, and with higher than industry standard security measures and sterling reputation as Canadian regulatory experts, they are recognized as a well-established firm with deep relationships with clients, partners, and regulatory authorities. “The opportunity to work with Susanne and SPharm for over 20 years testifies to the quality of work and the relationship one experiences with the SPharm team. They became an extension of our own, our success enriching our relationship over the course of business in parallel with a great friendship.” Jean De Serres, MD, M.Sc, MBA, I.As, VP Scientific Affairs and Operations, Paladin Labs.
The firm has a 99% submission approval rate, successfully contributing to market expansion, including taking a single client from a handful to over 50 health products, in less than 7 years. SPharm excels in therapeutic areas including plasma component deficiencies, cardiology, neurology, oncology, endocrinology, metabolism, rheumatology, microbiology, orthopedic surgery, dentistry, and gastroenterology. In the last decade alone, SPharm has facilitated over 1,500 submissions, including contributing to extremely challenging dossiers in a manner that facilitated the regulatory process and ensured approvals in record time in Canada, including getting health product approvals in Canada first, before any other country.
“It has been a memorable journey with a truly amazing team; I am honored to be working alongside such an intelligent, talented, hardworking, and driven team of professionals, and I look forward to the future with confidence and enthusiasm.” says Picard.
About SPharm Inc.
SPharm is a Canadian consulting firm specialized in strategic regulatory affairs, development, and approval services for health products (including drugs and medical devices). Their team of experts assists pharmaceutical, biotechnology, medical device, natural health product companies, and more from around the world throughout the various phases of their health product development, regulatory approval, and up to successful and timely market access, including life-cycle management post-market approval.