Regulatory Affairs Support

Achieve Your Development Objectives with Confidence

We help you achieve your regulatory development objectives by providing an array of services, including regulatory insight, strategy, and support.

Our services are tailored to meet the needs of small- and medium-sized domestic and foreign companies. We focus on regulatory affairs for pharmaceutical and biopharmaceutical development and commercialization.

End-to-end regulatory expertise for Canada and the U.S.

We also offer specialized services tailored to each product category:

Writing, review, and filing

New Drug Applications/Submissions (NDA, NDS)
Biologics License Applications (BLA)
Abbreviated New Drug Applications (ANDA, ANDS)
Post-authorization maintenance support/filings
Investigational/Clinical Trial Applications (IND, CTA)
Prescription to non-prescription switch
Product Monograph and mock-up development
Package insert and label development
Risk Management Plans (RMPs) and REMS
Master Files (MF)
Drug submissions relying on third-party data (SRTD)
Drug Identification Number (DIN) submissions
Comprehensive Summary of Bioequivalence (CSBE)
New Substance Notifications (NSN)
Orphan drug, breakthrough, and fast track designations
Pre-launch Importation Request (PLAIR)
OTC monograph
Establishment and drug listings
Access to Information (ATI) requests

Agent services

Canadian agent: NDS, ANDS, NSN, CTA, MF
U.S. agent representation

Submissions

Product classification/Request for designation
Applications for test kit numbers (controlled substances)
Clinical trial application guidance and submissions (ITA and IDE)
Licence applications (Class II, III, and IV) for medical devices and IVDs
Medical device marketing applications (510(k), PMA)

Agent services

U.S. agent representation

Clinical Trial Applications
Product License Applications (PLA): Class I, II, III
Cosmetic notifications
Ingredient assessment and label claim development
New substances notification (NSN) filings and compliance support

Agent services

Canadian agent: NSN, CTA, MF, Cosmetic