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Canada’s Drug Regulatory Experts

Looking for Regulatory Consultants to get approval for your Drugs, Medical Devices and other Health Products in Canada?

Benefit from SPharm’s over 25 years of experience, expertise and relationships.

Free Download – Answers to the most common questions and challenges about getting your Drugs approved for sale in Canada.

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.

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 Regulatory consultants for successful 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. SPharm Regulatory Consultants have the expertise to help guide you through the process.

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 Matters

SPharm consultants have 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.

Services

Services that help make the 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.

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Manage eCTD Submissions

The most efficient path to regulatory approvals is to have our regulatory experts also manage eCTD submissions.

Manage eCTD Submissions

The most efficient path to regulatory approvals is to have our regulatory experts also manage eCTD submissions.

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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.

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Training & Consulting

Offering training services to turn intimidating regulatory processes into more manageable ones.

Training & Consulting

Offering training services to turn intimidating regulatory processes into more manageable ones.

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Why choose SPharm as your 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

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.