IND Planning Resources to Get You There Faster
We are ideally positioned to support an efficient, rapid, IND submission to the FDA — for a review of the IND requirements, consult our Preclinical Assessment Planning Guide. Your submission needs to contain comprehensive information in three critical areas:
- Animal pharmacology and toxicology studies
- Manufacturing for producing the drug substance and the drug product
- Detailed protocols for proposed early clinical studies, including clinical investigators, necessary documentation and reviews, all within IND regulations
Altasciences’ Proactive Drug Development platform seamlessly integrates all of these key services, preclinical, manufacturing and early phase clinical, within an integrated partnership.
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.
You may also be interested in the following:
- Video: Preclinical Services
- The Altascientist: Safety Pharmacology Studies – a Review
- Fact Sheets:
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
Providing you with Cost-Saving and Quality Liquid-Filled Capsule Solutions
Our state-of-the-art equipment train and highly trained operators ensures that we can successfully deliver your liquid-filled capsule projects – simple or complex, large or small scale.
In this short video, our Vice President of Manufacturing, brings you inside our 30,000‑square‑foot, purpose-built, FDA‑inspected cGMP facility to provide you with a preview of our liquid-filled capsule manufacturing suite in Philadelphia, PA.
Contact us today for access to our full CDMO virtual facility tour video.
You may also be interested in the following:
January 2021
Most Promising Biotech Consulting Services Company
Bioanalytical Solutions for Biomarkers
Altasciences supports both preclinical and clinical studies covering many disease indications, such as oncology, metabolic disease, neurology, diabetes, inflammation, and more. Our integrated approach involves bringing in toxicologists and clinical pharmacologists to develop a comprehensive preclinical to clinical plan to maximize the translation of results from one phase to the next.
We will help guide you towards a robust and effective biomarker solution, using state-of-the-art technologies that include:
- Mass spectrometry
- Flow cytometry
- Cell-based assays
- Immunoassays
- Quantitative PCR
- Immunohistochemistry
Discover the difference.
Questions? Speak with our scientists.
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:
Setting the Foundation for Quality and Expertise in Drug Manufacturing
With the manufacturing and analytical capabilities to produce Schedule I to V products, Altasciences helps you accelerate your drug development program without compromising quality.
In this interview, Ben W. Reed, Vice President of Manufacturing, discusses Altasciences' unique drug manufacturing capabilities, talent acquisition, and running niche programs.
Do you have questions? Speak to an expert.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single service or a 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:
- On-Demand Webinar: Liquid-filled Capsule Expertise
- Case Study: Altasciences Fills Need of Leading Cancer Therapeutic Drug Developer
- Video Podcast: Overview of Manufacturing Capabilities
Over 20 Years of Bioanalytical Expertise
From discovery to preclinical to Phase IV, our team of over 200 highly skilled bioanalytical experts are ready to help you with your bioanalytical needs.
We deliver world-leading science, proven data integrity, regulatory expertise, and use state-of-the-art instrumentation to support both small and large molecule bioanalytical programs, including:
- Small and large molecule LC-MS/MS
- Microsampling
- Ligand binding assays
- Cell-based assays
- Biomarker quantitation
- Immunogenicity assessments
- Kit preparation
Find out more about how Altasciences can help you with your bioanalytical needs.
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.
You may also be interested in the following:
Premier Service Provider for Driving Simulator Clinical Trials
With over 13,000 simulated drives to date and the ability to accommodate up to 20 driving simulators on-site at once, Altasciences is the ideal full-service provider for your driving simulator clinical trials.
You can gather accurate driving performance data comparable in sensitivity to over-the-road testing, with faster study startup, lower cost, no risk of property damage, and no risk of injuries.
When working with Altasciences, you benefit from:
- A large database of study participants for ease of recruitment
- Professional oversight by fullycertified, in-house driving simulation study specialists
- Advanced 3D graphics that generate realistic representations of driving environment
- Automated measurement of psychomotor functioning, divided attention, situational awareness, and other cognitive behaviors
Click here for more in-depth information about our driving simulator capabilities, or contact our experts to discuss.
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:
The Altascientist: FDA Finalizes Drug-Impaired Driving Guidance
Video: Driving Simulation Studies
Fact sheet: Driving Simulation Studies