Regulatory Affairs
A Step-by-step Guide for Meeting Your Safety Assessment Start Dates
Careful planning and financial commitment can make the difference between starting your safety testing studies on time or experiencing significant delays.
Once you have determined your desired safety assessment start date, we recommend taking the following steps to ensure you start your studies on time, and on your terms.
- 12-18 months before:
- Schedule a meeting with the FDA to go over your safety assessment plan.
- 9-12 months before:
- Get quotations from your preferred CRO partners.
- After receiving the proposals, discuss your program with an expert toxicologist to ensure you captured all the required studies.
- 6-12 months before (depending on research animal species and study type):
- Choose a CRO partner and sign a contract.
Reach out to us today so we can go over these steps together and ensure your study starts on time.
Are You Looking for Help with Scientific Publications?
Scientific Publication Writing — Let Us Help!
Altasciences’ scientific experts can provide you with strategic guidance and quality writing for your next scientific publication. Our solution includes writing for a wide range of therapeutic areas, for your preclinical to clinical research — as part of a full‑service program completed at our facilities or as a stand-alone offering.
Benefit from:
- Strategic publication guidance and content development for manuscripts, posters, and abstracts
- Expert review and editing of your pre-written publications
- And more!
Have 5 minutes? You may be interested in:
- Comprehensive Research Support Capabilities
- Scientific, Regulatory, and Strategic Guidance
- Full-Time Equivalent Capabilities
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development 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.
FDA and EMA Prefer Terminal Sterilization Over Aseptic Manufacturing ― Find Out Why
Advantages of Terminal Sterilization Over Aseptic Manufacturing
Regulatory agencies such as the FDA and EMA generally prefer terminal sterilization over aseptic manufacturing, as it provides a high level of sterility assurance. It is also less complex, less costly, more easily reproducible than aseptic manufacturing, and offers time savings to pharmaceutical companies.
In this issue of The Altascientist, we discuss:
- Differences between terminal sterilization and aseptic manufacturing
- Sterilization methods for pharmaceutical products
- Validation steps during sterilization
- Method selection
Read to learn how terminal sterilization can benefit your drug product.
Questions? Speak with one of our experts? Contact Us.
Psychedelics — Regulatory Environment Challenges
A History of Public Attitude Towards Psychedelic Drugs
Psychedelic drugs exist within a unique social, legal, and historical environment, with roots in the public imag
Psychedelics — A New Era of Modern Medicine
The potential use of psychedelics for the treatment of various CNS indications is filling the drug development pipeline. Researchers in the field are examining modified chemical structures and analogs to psychedelics, to demonstrate efficacy and mitigate potential side effects.
In this podcast, Altasciences’ and DevelRx’s scientific experts examine the preclinical, clinical, and regulatory requirements and strategies that second-generation psychedelics may utilize to differentiate their pharmacological profile. We examine how to demonstrate efficacy and generate safety data that may distinguish psychedelics from first generation candidates.
Speak with an expert about your research needs.
You may also be interested in the following:
- Blog: Clinical Applications of Hallucinogens, Dissociatives, and other Schedule I Drugs
- Webinar: Navigating Early Phase CNS-Active Drug Development with Dr. Beatrice Setnik, CSO
- The Altascientist: CNS, Hallucinogens, and Other Schedule I Drugs
- Fact Sheet: Central Nervous System Capabilities
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.
The Next Trip: Developing the Second Generation of Psychedelics and Their Analogs for Targeted Medical Use
Following decades of stagnation, the field of psychedelic research is being revitalized by the investigation of their potential benefit for mainstream psychiat
Expert Support for Your IND/CTA Requirements
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Partnering with Altasciences for your IND/CTA needs will ensure that your application to regulatory agencies moves forward as smoothly and efficiently as possible. To reach your milestones on time, we recommend setting up a meeting to consult with us at least six months before your required submission date.
For a more detailed discussion of the regulatory planning process, consult our Preclinical Assessment Planning Guide.
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Moving Your Drug Forward to Preclinical Trials
Your drug discovery phase is nearing completion and your funding is in place. What comes next?
Navigating SEND with Altasciences
If you are struggling with getting SEND data, Altasciences can help. Our personable and accessible SEND team is ready and able to answer your questions throughout your SEND process.
As an active member of the CDISC SEND Consortium and Pharmaceutical User Software Exchange (PhUSE) nonclinical working groups, Altasciences contributes to the development of SEND standards and remains at the forefront of these evolving requirements.
Contact a SEND expert today and start saving time.
You may also be interested in the following:
- SEND FAQs: Ask These SEND Questions First
- Webinar: From Guides to Rules and How They Impact Your SEND Requirements
- Scientific Publication: The FDA Animal Rule and Standard for Exchange of Nonclinical Data (SEND)
- Webpages:
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.
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.