Who are we?

SPharm is a consulting firm specialized in Pharmaceutical/Medical Regulatory Affairs and Product Development Services.

SPharm's team of experts assists pharmaceutical, biotechnology, and medical devices companies around the world throughout the various phases of their product development up to a successful and timely market access.

We do this by providing strategic product development guidance as well as planning and preparation of quality regulatory dossiers which are specific to your company's needs.

How can we help you?

Unlike most regulatory companies SPharm does not only administer the regulatory process, SPharm puts its experience and expertise to work for you with a proactive and strategic approach that can save you time and money.

At SPharm, we do more than simple regulatory consultation work: we offer a partnership which will integrate your corporation’s strategies and processes.

How and why SPharm's strategic approach can save you time and money...

• Initially SPharm undertakes an evaluation of the particular regulatory situation of each dossier versus available scientific data;
• This initial integrated evaluation of the regulations provides the foundation for a strategic approach in building solid dossiers for regulatory approval;
• With SPharm's extensive regulatory experience, you are well positioned to anticipate and address proactively the potential questions and challenges of Health Authorities;
• This proactive approach for your regulatory dossiers will allow you to maximize the time to market of your products at minimal costs.

SPharm’s fields of expertise:

• Pharmaceutical, biological and biotechnological products including plasma derived products;
• Prescription and over-the counter (OTC) products;
• Medical devices;
• Natural health products;
• Various therapeutic areas such as cardiology, neurology, oncology, endocrinology, metabolism, arthritis, antibiotics, orthopaedic, dental, etc.

Offering much more than just regulatory consultation or dossier preparation, SPharm provides the advantages of a true partnership by ensuring that its services are fully integrated with your company’s processes, procedures and strategic objectives.

To find out more about the quality and scope of services we offer in both English and French, please contact today Susanne Picard, President, Tel.: (819) 824-6869.