Regulatory Affairs
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.
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.
Rapid Turnaround Medical Writing Solutions
Reliable and Robust Medical Writing Solutions
Altasciences’ expert writing services are offered as an integrated part of your study (or studies) or as a standalone service.
From design to final regulatory submission, we provide a range of writing solutions to ensure quality documentation for your clinical trials. We produce flexible, efficient processes for both small and large projects, and are able to expedite your request as needed. To meet global technical and regulatory requirements, we apply best practices for content, format, and style to in-house or sponsor-supplied document templates.
Contact our team of experts to learn more about our medical writing capabilities.
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.
You may also be interested in the following:
Fact sheet: Integrated Research Support Services
Webpage: Full-Time Equivalent (FTE) Capabilities
Webpage: Complementary CRO Research Services
Webpage: Comprehensive Clinical Trial Services
Clinical Applications of Hallucinogens, Dissociatives and other Schedule I Drugs
Following an initial period of study, mainly in the early 20th century, many hallucinogenic drugs had been dismissed as drugs of abuse with no clinical utility.
Complimentary Webinar — Regulatory Submissions in Canada vs. the U.S
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This webinar provides an overview of requirements for gaining approval to conduct a first-in-human (FIH) clinical trial via Health Canada’s Clinical Trial Authorization (CTA) process and the U.S. FDA’s Investigational New Drug (IND) submission process. Watch Altasciences’ Paul Sidney, Senior Director, Compliance and Regulatory Affairs, and Dr. Joe Francisco, Chief Toxicologist, as they provide insight as to how and why the conduct of FIH clinical trials in Canada may, in some cases, provide a more expedient method to gain human clinical safety data. |
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WEBINAR — A Guide to Interpreting the Certificate of Analysis
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Reference standards are required for regulated bioanalysis, and the quality and degree of characterization of the reference standard will depend on the stage of drug development. To evaluate if all requirements are met, it is important to understand the information provided within a reference standard certificate of analysis (CoA). |
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Rigorous Sample Handling Processes
Regulatory Guidance
Ensuring that current and relevant FDA and EMA guidances are applied to the handling of bioanalytical samples during clinical tria
Data that Meets Regulatory Guidelines Worldwide
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Robust planning early in drug development can save you both time and money. Altasciences' in-house pharmacokineticists and biostatisticians can work with you to build a robust strategy from the get-go. They are accustomed to managing complex projects with different partners, no matter the therapeutic area — your drug will be in expert hands. | |
From Lead Candidate to In-life Use
From Lead Candidate to In-life Use – Manufacturing Drugs from Formulation Development to Commercialization
Podcast Speakers:
Steve Schweibenz, President, Manufactur