Services
- Biorepository Solutions
- ULT Transport
- Unlicensed Medicines
- Patient Support Program
- Managed Access Program
- Post-Trial Access
- Early Access Program
- Clinical Trial Comparator Sourcing
- Clinical And Commercial Secondary Packaging And Labeling
- Clinical Trials Logistics
- Clinical Trial Material Storage and Distribution
- Global Logistics for Life Sciences
- Pharmaceutical Wholesale Distribution
- Specialty Medicines
- Regulatory Affairs Support
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.
Comprehensive regulatory support across Canadian and U.S. markets
In addition, we provide the following tailored services for 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