Clear your path to regulatory success with cross-functional expertise
Every day your therapy is delayed, patients wait. That’s why we bring together experts across regulatory pillars to help you understand the landscape and anticipate issues before they become problems. With over 25 years of experience in regulatory strategy, dossier authoring, submission preparation, and lifecycle management, we streamline your path to market.
Improve efficiency, and your chances for success
We guide your product through the full regulatory process with Health Canada or the U.S. FDA. Our strong agency relationships and deep expertise help you anticipate challenges, close data gaps, and advance with confidence.
I sincerely appreciate your valuable feedback and encouragement throughout this process. Your thoughtful comments have been truly motivating. The precision of your feedback and your prompt guidance significantly enhanced the quality of our work. I'm looking forward to future collaborations.
Our Services
We customize every service to meet your company’s unique needs.
- Advertising and promotional reviews
- Regulatory intelligence and advice
- Agency interface and meeting support
- Pre-submission strategy and product classification
- Due diligence and gap analysis
- Label development and regulatory/scientific writing
- Launch planning support
- Submission planning and lifecycle management
- Submission publishing and filing
- Training
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
What Sets Us Apart
Strategic foresight
Avoid costly missteps with a proactive approach and nuanced understanding of agency expectations.
Specialized regulatory knowledge
Tap into expertise across clinical/non-clinical disciplines, chemistry, manufacturing, and control (CMC), and other specialized areas to meet even the most complex requirements.
Broad product expertise
Navigate regulatory pathways for prescription and non-prescription pharmaceuticals, biologics, medical devices, cosmetics, natural health products, across Canadian and U.S. markets.
Integrated support
Access deep technical expertise in other areas — pharmacovigilance, medical information, quality, publishing, market access, and patient support programs — all under one roof.
Agency and association relationships
Leverage trusted connections with Health Canada, the FDA, quasi-regulatory bodies like PAAB, regulatory associations (including DIA, RAPS, and CAPRA), and numerous industry associations.
Flexible engagement
Find tailored support, whether you need on-demand consulting or a full-service regulatory department to act as an extension of your team.
I plan to recommend Innomar Strategies based on the excellent work I have seen you do firsthand with our mutual client. You are always on the ball, give practical advice, and provide great guidance to the client. It is always a pleasure to work with you.
Stay ahead with weekly regulatory intelligence and safety updates
Regulatory requirements change often. Staying informed is critical to maintaining compliance and protecting patient safety. Our weekly newsletters deliver the latest Canadian regulatory intelligence and global safety updates straight to your inbox, so you can act quickly and confidently.
We had the closing call for the MDEL inspection yesterday. In summary, some praise about our SOPs and impressed with the bi-annual reviews and how we implement changes in our SOPs. Thanks for this.
Discover more capabilities
Training
We also offer group and individualized training in the following areas to meet your needs:
