We've compiled new regulatory guidances and updates from the past couple of weeks, and are available to walk you through them. • FDA Guidance Draft — Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: https://lnkd.in/e5PhbBsf • FDA Final Guidance — Conducting Clinical Trials With Decentralized Elements: https://lnkd.in/exDQdykh • FDA Final Guidance — Providing Regulatory Submissions in Electronic Format | Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry: https://lnkd.in/faMsqTY • FDA Final Guidance — ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: https://lnkd.in/eZnhMk4v • EMA — Reflection Paper on Establishing Efficacy Based on Single-Arm Trials Submitted as Pivotal Evidence in a Marketing Authorization Application: https://lnkd.in/eSMjRCfG Have questions? Leave a comment below or reach out to us here: https://lnkd.in/gpjN3GE. #DrugDevelopment #RegulatoryGuidance #Pharmaceuticals
Altasciences
Research Services
Laval, Quebec 32,633 followers
Quicker go/no-go decisions with integrated preclinical, clinical, bioanalytical, manufacturing, and CRO services.
About us
Outsourcing made easy with a one-stop solution to early phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!
- Website
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http://www.altasciences.com
External link for Altasciences
- Industry
- Research Services
- Company size
- 1,001-5,000 employees
- Headquarters
- Laval, Quebec
- Type
- Privately Held
- Founded
- 1992
- Specialties
- Clinical Research, Clinical Trials, Phase I-II, Human Abuse Liability & Abuse Potential, Early Cardiac Safety & TQT, Biosimilars, Bioanalytical Laboratory, Analytical Services, Toxicology Study, CDMO, Safety Pharmacology, Preclinical Study, GLP / Non-GLP Study, IND-Enabling, NDA Submission, LCMS and LBA, Small and Large Molecule Bioanalysis, Research Support Services, Medical Writing, Clinical Project Management, and Pharmaceutical Manufacturing
Locations
Employees at Altasciences
Updates
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Join the conversation at the 20ᵗʰ Annual Meeting of the Oligonucleotide Therapeutics Society in Montréal, Quebec! As leading experts in the field, we’re excited to present our research on oligonucleotides and discuss Altasciences’ comprehensive solutions. Let us know when you’d like to connect via this link: https://lnkd.in/evRDjrn3 #OTS24 #ResearchAndDevelopment #Oligonucleotide Mingluan Chen Vaibhav Mehta Ph.D. Jean-François Dupuis Kevork Mekhssian Derek Storey
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Join Dr. Keyhani and Dr. Salha for their presentations during the Applied Pharmaceutical Analysis Conference in Boston, MA. Click here to request a copy or visit us at Table #2: https://lnkd.in/dKaG_6um #Bioanalysis #Biomarkers #ResearchAndDevelopment Anahita Keyhani Danielle Salha Jean-Francois Poulin, PhD, MBA
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LAST CHANCE TO REGISTER—Don’t miss our webinar on the multifaceted applications of GLP-1 drugs, from reducing inflammation to controlling lipid metabolism. Register today! https://lnkd.in/e7VZE4ir #Pharma #WeightLoss #ClinicalResearch
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We are in an era where combinations of entero-pancreatic hormones can deliver significant weight loss, and patients are experiencing health benefits beyond blood sugar and weight management. So what’s next for these groundbreaking therapeutics? We answered this question in a new article for Biopharma Dive. Read on: https://lnkd.in/g37hA7Xe #DrugDevelopment #Obesity #Glucagon
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Are you navigating the complexities of ADME and clinical pharmacology profiles in drug development? Join us at PBSS San Diego to discover how our team of seasoned DMPK/ClinPharm scientists can help you streamline your IND and NDA submissions. Pre-book a meeting time here: https://lnkd.in/dAGtMZUk #DrugDevelopment #ClinicalPharmacology #ADME Matt Stonehouse Charles Beaulieu Darren Craig
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A single water molecule may seem insignificant on its own but can transform the world. At Altasciences, bioanalysis is the science of revealing the unseen, transforming data into medicines that change lives. We leverage the synergy of three harmonized labs to unveil bold, innovative bioanalytical solutions. Partner with us to push your drug development program forward. #UnveilingTheInvisible #Bioanalysis #WeAreAltasciences #DrugDevelopment
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We’re at Contract Pharma today and tomorrow. Let’s connect! #CDMO #DrugDevelopment #ContractPharma
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Introducing Drug Development Digest—a newsletter in which our experts share valuable perspectives on topics essential to early-phase drug development. In our first article, Dr. Beatrice S., Chief Scientific Officer, sheds light on pharmacokinetic, pharmacodynamic, and toxicokinetic analyses, and their crucial role in early-phase studies. Read it now, and don’t forget to subscribe! #WeAreAltasciences #Pharmacology #Newsletter
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Altasciences has designed, conducted, analyzed, and reported on hundreds of DDI studies—from two-way crossover studies to the most complex, multi-cohort, adaptive designs. Here are a few highlights: • A sizeable patient database of poor and extensive metabolizers of different CYP enzymes. • Historical genotyping data for rapid recruitment— First Subject First Visit in approximately 10 weeks from the final protocol. • Clinical operations staff are accustomed to the fast pace and expertly manage 60 patients at a time. • Data Analysis, Medical Writing, and Scientific Affairs teams that deliver full-service, customized insight, including study design, rapid database development, biostatistics, and PK analysis, as well as executive summary analysis and detailed clinical study reports. #DrugDevelopment #ClinicalResearch #ClinicalTrials