Speak with an SPharm Advisor
Download Report
Our Regulatory Services
Since 1997, SPharm has provided Regulatory Services for pharmaceutical, biotechnological, natural health product and medical device companies from all over the world. Our team has over 60 years of combined experience in regulatory affairs and product development, it has contributed to obtaining numerous clinical trials and marketing authorizations for drugs, medical devices and other health products.
Our Track Record of Success
NUMBER OF SUBMISSIONS
Over 1500 submissions in the past 10 years
SUBMISSION SUCCESS RATE
Near 99% submission success rate
GLOBAL CLIENT LOCATIONS
SPharm has delivered regulatory services to clients in 15 different countries
Regulatory submissions and applications, including:
01.Clinical Trial Applications
02.New Drug Submissions
03.Investigational Testing Authorizations
04.Medical Device License Applications
Life Cycle Management activities, include:
01.Supplemental New Drug Submissions
02.Notifiable Changes
03.Annual Drug Notifications
04.Yearly Biologic Product Reports
Additional regulatory services related to drugs, biologic, biotechnological, medical devices, vaccine, veterinary, natural health, generic and biosimilar products include:
- Product Monographs, Investigator’s and Device Brochures writing
- Provincial Submissions
- Liaison with decision makers
- Review of labelling and of marketing materials
- Interface with PAAB
- Regulatory training and staffing
- Document translation and regulatory / scientific content validation
- Special Access Programme (SAP) support
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.
Find out what SPharm Regulatory Consultants can do for you.
Learn how our proven expertise can help reach your objectives faster. Contact us today.