Take a Virtual Tour of our State‑of‑the‑Art Clinical Laboratories
With over 25 years’ experience in clinical pharmacology, our experts provide comprehensive drug development solutions to get your molecule to clinical proof of concept. Our experienced team can guide you in the design and conduct of your studies in a wide range of therapeutic areas, including small molecules, biologics, 505(b)(2) and hybrid applications.
Combined, our clinical pharmacology units total 130,000 square feet and feature:
- Over 500 beds
- 10 on-site driving simulators
- On-site pharmacies
- Long-term stay facilities
- Upscale amenities for participants
- Outpatient and return units
- Participant screening facilities
- 24/7 security
Catch a glimpse of the facility here.
Request a full virtual tour of our clinical facilities or contact us for more information.
You may also be interested in the following:
- Webpages:
- Webinar: The Strategic Use of Cognitive Measures and Biomarkers in Early-Phase CNS Drug Studies
- The Altascientist: Central Nervous System Active Drugs ― Complex Considerations
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Altasciences Named Best Mid-Size Early Phase CRO (North America) and Leading Providers of Preclinical Safety Testing Services by GHP News at the 2021 Biotechnology Awards
Don’t Miss it ― a Regulatory Discussion with our Experts
Complimentary Webinar — Clinical Trials in Support of a U.S. Drug Submission
Did you know that first-in-human (FIH) clinical trials conducted in Canada can accelerate regulatory approvals from the EMA and the U.S. FDA?
For an overview of foreign health authority requirements for approval to conduct a FIH clinical trial, including a comparison of Health Canada’s and the EMA’s Clinical Trial Authorization (CTA) processes and the U.S. FDA’s Investigational New Drug (IND) submission process, watch this complimentary webinar.
Topics covered include:
- Ensuring timely FIH clinical trials when planning your early phase drug development strategy
- Utilizing foreign clinical trials for U.S. FDA drug submissions and approvals
- Differences in the quality and nonclinical data submission requirements to gain EMA, FDA, and Health Canada approval to conduct FIH trials
Contact us to discuss the additional benefits of conducting FIH trials in Canada.
You may also be interested in the following:
- Webpage: Scientific, Regulatory, and Strategic Guidance
- Fact sheet: Clinical Sample Collection Kits
- Fact sheet: First-in-Human (FIH) Studies
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Take a Virtual Tour of our State‑of‑the‑Art Preclinical Facility
With over 25 years’ experience conducting safety assessment, Altasciences’ preclinical facility in Seattle offers a wide array of solutions, including IND/CTA and NDA-enabling safety assessment, as well as laboratory services for both small and large molecules.
In this 210,000-square-foot, purpose-built facility, Altasciences can thoroughly assess the safety of your molecules with a full range of in vivo GLP and non-GLP preclinical evaluation studies in both rodent and non-rodent species. We’ve conducted over 2,400 safety studies at this site, which features:
- 140 custom-design animal rooms, including European housing
- 4,500 sq.-ft. archive facility
- Capacity to house ~3,000 NHPs, ~500 Canines, ~100 Swine, ~12,000 Rodents, ~800 Rabbits
- AAALAC accreditation
- USDA registration
- OLAW assurance
- BSL-2 certification
Catch a glimpse of the facility here.
Request a full virtual tour of our Seattle site or contact us for more information on our newest preclinical site in Scranton.
You may also be interested in the following:
- Webpage: Preclinical Drug Development Solutions
- Podcast: Science, 3Rs, and Animal Welfare with Dr. Megan R. LaFollette from 3RNA
- Webinar: Comparison of the U.S. FDA and Health Canada CTA submission Process to Support First-in-Human Phase I Studies
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Take a Tour of our State-of-the-Art Manufacturing and Analytical Facility
From formulation to commercialization, Altasciences’ 64,000 square-foot, purpose-built FDA-inspected GMP facility features an analytical lab, a Research & Development formulations lab, and multiple manufacturing suites with cutting-edge Grade C cleanrooms, including segregated and dedicated potent handling areas. Our CDMO experts have over 100 years of combined experience in the management of pharmaceutical manufacturing and laboratory operations.
Our expertise includes:
- Liquid and powder-filled capsules
- Nano-milled suspensions
- Creams
- Powders
- Terminally sterilized injectables
Catch a glimpse of the facility here.
Request a full virtual tour of our Philadelphia site today or contact us.
You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
- The Altascientist: Maximizing Drug Formulation for First-in-Human Trials
- Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials
- Podcast: Altasciences’ Manufacturing Solutions, Liquid-Filled Capsules
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Five Things you Need to Know about Scientific Affairs
Q&A with Catherine Dussault, Director of Scientific Affairs
| Successful early phase drug development studies are grounded in a strong scientific rationale, and a deep understanding of regulatory requirements. Altasciences’ Scientific Affairs (SA) team combines these critical knowledge bases to support sponsors in designing and conducting the most appropriate studies for their unique development program. |  Catherine Dussault, Director, Scientific Affairs, Altasciences |
Read the five things you need to know
Catherine Dussault is the Director of Altasciences’ Scientific Affairs team. She has been with Altasciences since 2004; and is a senior scientific leader with a deep knowledge of regulatory framework for various drug development clinical research programs. Catherine has overseen over 2,000 clinical trials, including Phase I and II, FIH, bioequivalence, 505(b)(2), drug-drug interactions, QTc, and proof of concept, in both healthy normal and special patient populations. She has extensive experience in multiple therapeutic areas, such as central nervous system, GI tract and metabolism, cardiovascular, genito-urinary system and sex hormones, antineoplastic and immunomodulating, and anti-infective agents.
Your Trusted Partner for Bioanalysis
We are your one-stop solution for all your bioanalytical needs. We offer fully integrated bioanalytical laboratories that support our facilities and clinical sites. Most importantly, we ensure the success of your projects by anticipating challenges throughout the process with:
- A team of industry recognized, subject matter experts specialized in both small and large molecules
- 25+ years of regulatory experience
- Strategically located facilities situated in proximity to preclinical and clinical sites
- A history of successful regulatory inspections
- Industry leading experience with GLP and GCP regulatory processes
- In-depth knowledge and experience with preclinical, first-in-human SAD/MAD, and Phase III bioanalytical study management and timelines
Partner with Altasciences today.
You may also be interested in the following:
- Factsheets:
- Video: Bioanalysis Services
- Webinar: Transitioning Novel Scientific Workflows to Routine Bioanalysis
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Small Molecule, Nonclinical Drug Development Solutions
As your drug development partner, we have a deep appreciation of both the challenges and the potential of your small molecule. At Altasciences, we understand why developing your molecule requires tailored solutions at every stage.
Find out how our small molecule solutions help identify new and improved approaches to study designs, and anticipate development challenges as studies evolve.
Bring us your challenge. We have the solution.
You may also be interested in the following:
- Factsheet: Small Molecule Safety Assessment
- IND/CTA Guide: Planning your Preclinical Assessment
- Webpage: Bioanalytical Services
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.