Management of your Clinical Trial Applications and timely marketing authorization from Canada’s Drug Regulatory Experts – SPharm

Effective management of drug development plans, Clinical Trial Applications and obtaining a marketing authorization require thorough knowledge of the drug approval process, regulations and an excellent product development strategy. SPharm offers you its expertise to ensure efficient project management, aiming for a marketing authorization within the best possible timeline.

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Why choose SPharm
as your regulatory experts?

SUCCESS RATE

of submissions close to 100%

EXPERIENCE MATTERS

Over 20 years leading in Canadian regulatory affairs

UNMATCHED EXPERTISE

of Canadian Health regulations and guidance

HIGH CLIENT SATISFACTION

resulting in long term business relationships

STRATEGIC RELATIONSHIPS

with Health Authorities at all levels

CHALLENGING GUIDELINES

Experience with submissions challenging the regulatory guidelines

Explore SPharm’s range of services

Pharmaceutical Regulatory

  • Regulatory submissions with Health Canada
  • Lifecycle management for drugs and medical devices
  • Complementary services
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Product Development

  • Due diligence
  • Strategic health product development
  • Brand name analysis
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Pharmacovigilance

  • Clinical trials and Post-marketing surveillance programs
  • Risk Management Plans (RMP)
  • Pharmacovigilance training
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Compliance and Quality

  • Quality due diligences
  • Drug Master Files (DMF)
  • Establishment Licences (EL)
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Services through our partners

  • Foreign regulatory affairs
  • Ethics Review Board
  • In vivo nonclinical studies
  • Monitoring of Clinical Studies
  • Clinical trial report writing
  • Statistical analysis
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SPHARM, CANADA’S DRUG REGULATORY EXPERTS

Fields of Expertise

SPharm can help you succeed in your projects in several areas of expertise:

  • Therapeutic, biologic and biotechnological products
  • Prescription and over-the-counter products
  • Medical devices
  • Natural Health Products
  • Generic products
  • Veterinary products
  • Food and food ingredients
  • Cosmetics

Therapeutic Classes

Through the years and mandates, we have successfully handled dossiers involving various therapeutic classes:

Plasma components deficiencies

 Cardiology

 Neurology

 Oncology

 Endocrinology

 Metabolism

 Rheumatology

 Microbiology / Antibiotics

 Orthopedic surgery

 Gastroenterology

 Dentistry

 Etc.

Customer

Testimonials

  • « 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

Insights/Blog

Overcoming Obstacles in the Drug Approval Process in Canada
2021 Covid-19 Vaccines Update
Covid-19 Vaccines Summary

1 819.824.6869

1235, 3e Avenue
Val-d’Or, Québec,
Canada   J9P 6C3

info@spharm.ca



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