Free Download – In this guide, you will learn what we have encountered as the most common obstacles in the Canadian Drug Market Access industry and how to side-step or overcome them.
Read this guide before you start the regulatory approval process in Canada. SPharm will help turn a seemingly complex or intimidating regulatory approval process into a more manageable and predictable one.
Canada's Regulatory Experts for Drug & Health Products.
Pharmaceutical, biotechnology, natural health product and medical device companies from around the world count on SPharm Regulatory experts and consultants for successful Clinical Trial Application approval with Health Canada and timely market access of drug and health products in Canada.
Regulatory Expertise Matters
Effective management of health product development plans, Clinical Trial Applications and obtaining marketing authorization in Canada requires thorough knowledge of the Health Canada regulatory approval process and local regulations. SPharm Regulatory Consultants have the expertise to help guide you through the process.
Regulatory Affairs Strategy Matters
Our regulatory consultants go beyond the scope of simply providing 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 in Regulatory Affairs Matters
SPharm consultants have helped companies navigate Health Canada regulatory requirements for over 25 years and is supported by a team of drug regulatory experts with an envious record of successful Health Canada filings.
Health Canada Regulatory Services
Services that help make the drug and health product regulatory process more manageable, predictable and successful.
Regulatory
Services
Regulatory submissions and life cycle management of drug, medical device and other health products for Canada.
Regulatory
Services
Regulatory submissions and life cycle management of drug, medical device and other health products for Canada.
Discover this service »Clinical Trial
Applications
Our team streamlines the application process and increases the probability of a successful CTA.
Clinical Trial
Applications
Our team streamlines the application process and increases the probability of a successful CTA.
Discover this service »eCTD
Submissions
The most efficient path to regulatory approvals is to have our regulatory experts also manage eCTD submissions.
eCTD
Submissions
The most efficient path to regulatory approvals is to have our regulatory experts also manage eCTD submissions.
Discover this service »Product Development
Offering a full range of services covering all aspects of drug, medical device and other health products development.
Product Development
Offering a full range of services covering all aspects of drug, medical device and other health products development.
Discover this service »Browse our Regulatory Resource Library
A Comprehensive Library to help you get your Drug, Medical Device, or other Health Products approved in Canada.
Drug Regulatory Process in Canada
Why choose SPharm as your Health Canada regulatory consulting experts?
SUBMISSION SUCCESS RATE
Near 100%
HIGH CLIENT SATISFACTION
Resulting in long term business relationships
EXPERIENCE MATTERS
Almost 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
Drug Regulatory Tips & Insight
Read articles, tips, how-to guides and industry insight on the regulatory and drug approval process in Canada
Customer Tesimonials
SPharm's professionalism, rigour and diligence fully met our expectations and contributed to the success of our projects.
Scientific Research Client
We have worked with Susanne and her team for over 16 years on various projects. Without fail, her team has been able to provide superior advice well thought out solutions. SPharm's exceptional track record and rapport with Health Canada adds value to all endeavours.
International CRO Client
The SPharm team has consistently provided results that exceeded my expectation. Congrats!
Pharma Client
SPharm has proven time and time again their professionalism, responsiveness and reliability in all of our dealings.
Medical Supplies Client
You did a tremendous job of positioning this dossier and documenting it. A really tremendous step forward. Thank you so much!!
Pharma Client
Find out what SPharm Regulatory Consultants can do for you.
Learn how our proven expertise can help reach your objectives faster. Contact us today.