FRD





FULCRUM RESEARCH AND DEVELOPMENT

Your Strategic Partner in Preclinical Drug Development

WHO WE ARE


We are a Partner Research Organization (or PRO) based in the heart of Montreal with deep-rooted experience in non-clinical drug development for the pharmaceutical industry.We provide access to seasoned preclinical, regulatory, and development professionals—with 15‑25 years’ experience—bounding scientific insight and regulatory savvy into your team.Our team comprises experienced scientists and regulatory professionals with deep expertise across key areas of drug development, including ADME/PK, bioanalysis, CMC, pharmacology, and toxicology. We work to ensure that all programs meet the highest standards of regulatory compliance and scientific rigor.


Driven by Science. Focused on Partnership.

OUR VISION


Fulcrum R&D's mission is to empower emerging and midsize biopharmaceutical companies like yours, guiding you with expert precision to uncover tailored solutions at every critical stage of your journey.At the core of our organization lies our industry-leading, multidisciplinary team, the driving force behind every biotech innovation we support. From the careful selection of lead drug candidates to the realization of human clinical proof-of-concepts, our experts provide unwavering guidance and expertise at every stage of drug development.With us by your side, you’ll navigate the complexities of the industry with confidence, knowing that each step forward is supported by a partner who is as invested in your success as you are.

WHAT WE DO


We provide program management, monitoring and support a broad range of drug modalities and development programs, including:- Small Molecules
- Peptides & Proteins
- Antibodies & Drug Conjugates
- Oligonucleotides
- Vaccines
- Cell and Gene Therapies
Therapeutic and Regulatory Programs
- IND- and NDA-enabling studies
- Bioanalytical method development and validation
- Pharmacokinetic (PK) and toxicokinetic (TK) Analysis and Modeling
- Safety pharmacology
- Genetic toxicology
- Carcinogenicity studies
- Developmental and reproductive toxicology (DART)
- Dose range finding and repeat-dose toxicity studies
- Specialized and exploratory toxicology
- Pathology review and interpretation
Our subject matter experts provide hands-on leadership and strategic insight to ensure every program progresses efficiently and in alignment with regulatory expectations.

Our program management services include:- site identification and initiation
- contract and budget negotiations
- project monitoring
- data management
- electronic data collection
- PK/TK modeling
- biostatistics
- medical writing

From discovery to IND-enabling studies, FRD delivers agile, science-driven solutions tailored to your pipeline needs.


HOW WE WORK


1. Strategic Planning – We map out preclinical and regulatory milestones.2. Integrated Execution – We manage CRO partnerships, study quality, and budgets.3. Regulatory Engagement – We prepare submissions, communicate with agencies, and monitor feedback.4. Risk Management – We ensure proactive issue-solving at every step to keep programs on track.

WHAT YOU CAN EXPECT FROM US


- Reduce the time needed to initiate projects- Focus on best-of-class provision of specific services- Provide targeted, cost-effective use of experienced professionals- Simplify complex processes with quality measurements- Increase and decrease resources and activity without affecting the internal headcount- Allow sponsors to focus on their core competencies- Manage multiple vendors through a central point of contact



Agile, Cost‑Conscious, and Scientifically Rigorous.

OUR SERVICES


Product Development Plan
- Collaborate with a team of diverse experts to refine study designs and reduce development risks and costs. Receive a comprehensive clinical plan outlining timelines, costs, regulatory insights, and trial requirements—serving as the foundation for Pre-IND meeting preparations.
--- Pre-IND submission and meeting attendance
--- IND, NDA, and ANDA preparation, submission, and maintenance
Outsourcing Logistics
- Our seasoned drug development team helps accelerate decision-making by offering RFP management, personalized study support, full-scale GxP program execution, and access to vetted, compliant research partners and sites.
--- CRO partner qualification, protocol reviews and quality oversight
--- Invoice management
Non-Clinical Support and Project Management for:
- In vivo disease models
- PK/PD correlation, dose selection
- Toxicology & Safety Pharmacology
- Dose‑range finding, GLP repeat‑dose, cardiovascular & CNS safety
Regulatory Strategy & IND Support
- Pre‑IND meeting prep
- Submission dossier drafting
- Regulatory liaison and labeling support
Bioanalysis, PK/TK & Biomarkers
- LC‑MS/MS, immunoassays, histopathology
- Pharmacokinetic and Toxicokinetic Modeling


Ready to Accelerate Your Preclinical Program?


Partner with Fulcrum Research & Development to access expert-driven, flexible, and efficient support for your drug development journey.

Let’s turn your molecule into a milestone.

Contact Us Today – and move your program forward with confidence.

Fulcrum Research & Development
2365 Saint Patrick, Suite 207
Montreal, QC, H3K 1B3
Canada

© 2022. All rights reserved.