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Canada’s Drug Regulatory Experts

Obtain Marketing Authorization in a timely manner 

About our company

More than a consulting firm, we are regulatory experts.

SPharm is a Canadian consulting firm specialized 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 throughout the various phases of their product development, regulatory approval, and up to successful and timely market access. For every mandate, we favour a strategic approach; we proceed in the best economic interest of our clients.

Drug and other Health Product Regulatory Affairs, Development & Approval Services.

Pharmaceutical, biotechnology, natural health product and medical device companies from around the world count on SPharm for successful regulatory approval and timely market access in Canada. 

Expertise Matters

Effective management of health product development plans, Clinical Trial Applications and obtaining marketing authorization in Canada requires thorough knowledge of the regulatory approval process and local regulations. 

Strategy Matters

Our expertise goes beyond the scope of simply providing regulatory consultation and dossier preparation. SPharm provides a true partnership by ensuring its services are fully integrated with your company’s internal procedures and strategic objectives.

Experience matters

SPharm has helped companies navigate Canadian regulatory requirements for over 25 years and is supported by a team of specialists with an envious record of successful regulatory filings.

Areas of Expertise

Our expertise covers therapeutic areas such as plasma component deficiencies, cardiology, neurology, oncology, endocrinology, metabolism, rheumatology, microbiology, orthopedic surgery, dentistry, gastroenterology, etc. We also provide regulatory services for the following product areas:

Pharmaceutical products

Biological/Biotech

Prescription products

Over-the-counter products

Orphan Drugs

Generic & Biosimilars

Medical Devices

Cannabis Products

Natural Health Products

Food & Food ingredients

Cosmetics

Veterinary Products

History of SPharm

In 2000, Susanne Picard created SPharm. Prior to becoming a consultant in pharmaceutical / medical regulatory affairs in 1997, Susanne held key regulatory and management positions in two multinational pharmaceutical companies and in a contract research organization. Susanne is a pharmacist with a Master’s degree in hospital pharmacy.

Susanne, now having over 30 years of experience in regulatory affairs, is supported by a team of specialists and has an envious record of successful regulatory filings. The entire SPharm team provides their extensive experience in all key regulatory product areas and in various therapeutic fields to the benefit of their clients.

Find out what SPharm can do for you.

Learn how our proven expertise can help reach your objectives faster. Contact us today.