eCTD Submission Services

Our scope of work includes electronic Common Technical Document (eCTD) publishing services. The most efficient path to regulatory approvals is to have your regulatory expert(s) also manage eCTD submissions. We work in close collaboration with your technical publishing team applying the strictest of regulatory affairs compliance to the publishing process and ensuring the most efficient electronic submission success and successful market access.

What is a Common Technical Document?

The CTD format originates from the International Conference on Harmonization (ICH) initiatives, in their effort to harmonize efficacy, safety and quality (chemistry and manufacturing) requirements globally for the registration of drugs (pharmaceuticals, biologicals, genetic therapies, etc.) for human use. This initiative includes standard information organization for new drug registration applications.

CTD TRIANGLE

The CTD format is divided into five modules: Module 1 contains region-specific information and Modules 2–5 contain common clinical, nonclinical and quality information with some regional variations.

The Module 1 (regional) includes the following, amongst other information:

Administrative form
Product Monograph
Mock-up of Inner and Outer labels
Certified Product Information Document
Brand Name Analysis
Risk Management Plan
Etc.

We, at SPharm, have earned a proud reputation for being skilled and multidisciplinary professionals, well-known for being responsive and efficient when facing short timelines with high workload and adjusting to client and regulator agency’s needs at all times.

Our Track Record of Success

NUMBER OF SUBMISSIONS

Over 1500 submissions in the past 10 years

SUBMISSION SUCCESS RATE

Near 99%

CLIENT LOCATIONS

SPharm has delivered regulatory services to clients in 15 different countries

Read About SPharm's Regulatory Milestones

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.

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