The SPharm pillars
SPharm is a Canadian consulting firm specialized in health product (drug, medical devices) regulatory affairs, approval & development services.
SPharm’s team of experts assists pharmaceutical, biotechnology, natural health products and medical device companies from around the world throughout the various phases of their product development, regulatory approval and up to a successful and timely market access.
SPharm detains the philosophy of a small organization. It is key to us to maintain a human dimension and a personal approach while offering high quality services at a reasonable cost.
For every mandate, we favor a strategic approach; we ensure to proceed in the best economic interest of our clients.
SPharm produces results:
- Success rate of regulatory submissions close to 100%
- Over 50 years of combined experience in regulatory affairs
- An excellent knowledge of Canadian and foreign regulations and guidance
- Strategic business relationships with Health Authorities at all levels
- An efficient project management structure to respect established timelines
- A high level of client satisfaction resulting in long term business relationships
- Creative and ingenious thinking
- Solution oriented
- Deliver according to clients’ and Regulatory Authorities’ needs
- Turnkey global regulatory approach, thanks to our global partners
- Experience with successful appeal procedures
- Experience with submissions challenging the regulatory guidelines
Areas of expertise:
Our expertise covers various therapeutic areas such as plasma component deficiencies, cardiology, neurology, oncology, endocrinology, metabolism, rheumatology, microbiology, orthopedic surgery, dentistry, gastroenterology, etc.
- Pharmaceutical, biological and biotechnological products
- Prescription and over-the-counter products
- Orphan Drugs
- Medical devices
- Natural health products
- Generic products
- Veterinary products
- Food and food ingredients
Contact us directly to find out more about the quality and scope of services.
More on who we are:
Our expertise goes beyond the scope of simply providing health product regulatory consultation and dossier preparation. SPharm provides the advantages of a true partnership by ensuring that its services are fully integrated with your company’s internal procedures and strategic objectives.
The corporate mandate of SPharm is to offer high quality professional and personalized pharmaceutical / medical regulatory affairs, product approval & development and related services.
SPharm not only administers the regulatory process, but also puts its experience, expertise and network of partners to work for you with a proactive and strategic approach that can save you time and money.
History & Team:
In 2000, Susanne Picard, creates SPharm Inc. 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 was also a pharmacist with a Master’s degree in hospital pharmacy.
Susanne, now having over 25 years of experience in regulatory affairs, is supported by a team of specialists. She has a wide record of fruitful and successful regulatory filings. She brings to SPharm her extensive experience in all key regulatory product areas and in various therapeutic fields. SPharm’s team of experts compiles over 50 years of experience in regulatory affairs and strategic product development.