Manufacturing and Analytical Services
A Solution to Drive Your Drug Development Forward
Nonclinical and Clinical Research Services — Phase I to IV
Whether you are looking for a full-service solution or a stand-alone offering, Altasciences will help guide you along the way. We are accustomed to managing complex projects with different partners, and have robust communication and operational processes in place to ensure efficient integration.
We offer a range of services for early phase and late phase studies, including:
- Program Management
- Clinical Monitoring
- Scientific Publication Development and Review
- Protocol Development and Medical Writing
- PK/PD Analysis and Interpretation
- Data Management
- Biostatistics and Statistical Analysis
- Support Services for Non-Clinical Studies
Have 5 minutes? You may be interested in this:
- Clinical Trial Services
- Podcast — Choosing the Right CRO for Your Clinical Trial Monitoring
- Blog — Five Things You Need to Know About Partnering with an Integrated CRO/CDMO
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.
Manufacturing Solutions for Your Ophthalmic Products
Ophthalmic Drug Delivery
Altasciences’ CDMO experts can support your ophthalmic drug development program for a wide range of ocular diseases. We take you seamlessly from the clinic to market, with high-quality formulation development and manufacturing of various dosage forms, including liquids, gels, and injectables.
Altasciences’ specialties include:
- All small molecule ophthalmic products, including potent compounds and controlled substances
- GMP/GLP-compliant, FDA-registered facility, with DEA License for Schedules I-V
- Class C manufacturing suites for development and clinical/commercial batches
- Flexible filling options, including vials, tubes, multi-dose bottles, cartridges, pre-filled syringes, droppers, and custom containers
- Terminal sterilization of your ophthalmic drug products
- Scale options from small batches up to 400L
- Milling capabilities for micro and nanosuspension products
- Analytical support for method development, validation, and ICH stability testing
- High-performance, mucoadhesive topical excipients
- Bioadhesive, monograph-compliant topical excipients
- Packaging of your ophthalmic therapeutics
- Regulatory, scientific, and operational guidance
Book a consult with one of our experts to learn more about our solutions and how we can support your program.
You may also be interested in the following:
- Fact Sheet: Comprehensive Services for Ophthalmic Drug Development
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Service
Did you miss our webinar titled “The Development of Nanosuspension Formulations for Poorly Soluble Drugs”? View it ON-DEMAND!
Experts in Complex and Customized Formulations
Over 80% of drugs will fail during clinical development due to formulation challenges. Having developed, tested, and manufactured almost every type of dosage form on the market, Altasciences has the expertise to customize our services to your API’s needs, taking it through its entire lifecycle and ensuring its successful delivery ― from prototype formulation development, to scale-up and ICH stability, to clinical manufacturing and commercial supply.
Our scientists tailor your drug compound to ensure optimal solubility and bioavailability. In addition, we have extensive experience handling complex and highly potent products. Finally, our state-of the art technology and banding equipment make us leaders in the development of hard-shell, liquid-filled capsules ― a dosage form often required for poorly soluble, highly potent or low dose APIs.
Partner with us today to reduce your development timelines and risk of product failure.
You may also be interested in the following:
Looking to Outsource Your Drug Development and Manufacturing?
Your Drug Development and Manufacturing Partner ― Altasciences at a Glance
Altasciences can support your drug formulation, development, and manufacturing needs, from formulation through to commercialization.
We excel in the full range of drug development and manufacturing solutions, including:
- Handling complex formulations and highly potent compounds (HPAPIs)
- Custom formulation development
- Manufacturing of liquid-filled, hard-shell capsules
- Nanomilling – to resolve solubility and bioavailability challenges
- Terminal sterilization
In addition, our integrated CRO/CDMO end-to-end solutions can reduce your drug development program timeline by up to 40% ― from discovery to preclinical to clinical proof of concept, and beyond.
Partner with us today.
Got a few more minutes?
| See our full range of drug development and manufacturing solutions. | Take a tour of our manufacturing facility and analytical laboratories. |
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Did you miss our webinar titled “The Development of Nanosuspension Formulations for Poorly Soluble Drugs”? View it ON-DEMAND!
Liquid-Filled Capsules – The Key to Accelerating Drug Development
Benefits of Liquid-Filled Capsules for Pharmaceutical Development
Liquid-filled, hard-shell capsules (LFCs) offer many advantages over tablet and other solid oral dosage formulations, including quicker drug development.
In this e-book, learn about:
- The top five benefits of LFCs over other solid oral dosage forms
- Applications for challenging APIs
- Logistical advantages
- How liquid filling works
- Advances in capsule binding technology
- Customization options
Questions? Speak with one of our experts.
Did you miss our webinar titled “The Development of Nanosuspension Formulations for Poorly Soluble Drugs”? View it ON-DEMAND!
Benefits of Liquid-Filled Capsules in Pharmaceutical Development
Five Things You Need to Know About Partnering with an Integrated CRO/CDMO
We are often asked about the advantages of working with an integrated CRO/CDMO.
Top Scientific Resources of 2021
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With the year coming to an end, we rounded-up some of our most insightful scientific resources from 2021. Check out what you may have missed, discover more about our areas of expertise, and learn how we can help you accelerate your drug development program. |
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Have five more minutes? You may be interested in:
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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.