Ensure efficient management of your Clinical Trial Applications and obtain timely marketing authorization with SPharm

Effective management of drug development plans, Clinical Trial Applications and obtaining a marketing authorization require thorough knowledge of the current 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.

Why do business
with us?

DEEP KNOWLEDGE

of Canadian regulations on health products

STRATEGIC AND TRANSPARENT BUSINESS RELATIONS

with governmental authorities

EFFICIENT PROJECT MANAGEMENT

meeting the timelines

HIGHLY SATISFIED CUSTOMERS

and lasting business relationships

MARKETING AUTHORIZATION

in a timely manner

Explore SPharm’s wide range of services

Regulatory

  • Regulatory submissions
  • Lifecycle management for drugs and medical devices
  • Complementary services

Product Development

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

Pharmacovigilance

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

Compliance and Quality

  • Quality due diligences
  • Drug Master Files (DMF)
  • Establishment Licences (EL)

Services through our partners

  • Foreign regulatory affairs
  • Ethics Review Board
  • In vivo nonclinical studies
  • Monitoring of Clinical Studies
  • Clinical trial report writing
  • Statistical analysis

SPHARM, YOUR BUSINESS PARTNER

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 met our expectations and contributed to the success of our projects. »

    Jocelyn Dupuis, MHI
  • « I 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. »

    Joanne Watson, JSS Research
  • « The SPharm team has consistently provided results that exceeded my expectation. Congrats! »

    Robert Vincent, Searchlight Pharma
  • « SPharm has proven time and time again their professionalism, responsiveness and reliability in all of our dealings. »

    Marty Tenenbaun, Trimedic
  • « You did a tremendous job of positioning this dossier and documenting it. A really tremendous step forward. Thank you so much!! »

    Mark Nawacki, Searchlight Pharma

Insights/Blog

1 819.824.6869

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



SPharm © 2018 All rights reserved | Powered by Red Dream Studios