Why choose SPharm?

    Why choose SPharm as your Health Canada regulatory experts?

    SPharm is known as Canada’s Drug and Health Canada Regulatory Experts specializing in health products (including drugs and medical devices) regulatory affairs, development & approval services. Our team of experts assists pharmaceutical, biotechnology, natural health product and medical device companies from around the world through the various phases of product development, Health Canada regulatory approvals, market access and life cycle management post approval.

    SUBMISSION SUCCESS RATE

    Near 100%

    HIGH CLIENT SATISFACTION

    Resulting in long term business relationships

    EXPERIENCE MATTERS

    Three decades leading in Canadian regulatory affairs

    STRATEGIC RELATIONSHIPS

    With health authorities, clients & partners

    UNMATCHED EXPERTISE

    With Canadian health regulations and guidance

    CHALLENGING GUIDELINES

    Experience with submissions that challenge regulatory guidelines

    PROJECT MANAGEMENT

    That respects established timelines

    APPEALS PROCESS

    Experience with successful appeals procedures

    A Full Range of Services
    Helping you turn intimidating regulatory approval processes into more manageable ones.

    Regulatory
    Services

    Regulatory
    Services

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    Clinical Trial
    Applications

    Clinical Trial
    Applications

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    Manage eCTD Submissions

    Manage eCTD Submissions

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    Product Development

    Product Development

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    Pharmacovigilance

    Pharmacovigilance

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    Compliance & Quality

    Compliance & Quality

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    A Key Factor in Our Clients' Success

    “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 Canada.”
    Julie Martin
    CEO and Co-owner, Scimega
    “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
    “We have had the pleasure of working with SPharm since the inception of our company, and since then SPharm has consistently exceeded our expectations in terms of service, timeliness, and deliverables. They have been a key factor in the success of our pharmaceutical company.”
    Robert Vinson, Ph.D.
    Chief Innovation Officer, Searchlight Pharma Inc.
    Discuss your project with SPharm.

    Contact the team at SPharm to discuss your projects, receive a proposal, advice, training or simply to get a second opinion.