Phase I-IIa Pharmaceutical Product Manufacturing for Clinical Trials
Working hand-in-hand with Avomeen takes an incredible amount of the burden of making supplies for your clinical trials off of your workload. Our highly-trained and knowledgeable scientists will help you move quickly and efficiently from preclinical testing into clinical development, performing CMC development, formulation, as well as manufacturing through Phase IIa.
We are experts at solving the complex problems that can arise during the Formulation & development process, and our full-service pharmaceutical development laboratory can support you in all stages of the development process.
Avomeen provides clinical trial material manufacturing services for phase I-IIa oral and topical pharmaceutical products.
Avomeen’s team of analysts at our formulation and testing laboratories has worked with an incredible assortment of clinical materials and manufacturers to create some of the world’s most effective products and medicines, including:
Manufacturing Specialization & CTM Production Processes
When you choose Avomeen as your CTM manufacturer, you enjoy the full range of manufacturing specializations, including production processes such as:
- Filtration, Granulation, Compacting, Mixing, and Filling
- Spray Drying
- Pellet (Bead) & Powder Encapsulation
- Powder Blending & Tableting
- Liquid & Cream Manufacturing
- Container/Closure Selection
- Scale-Up & Technology-Transfer
Clinical Supply Services
- Trial Batch Manufacturing
- Placebo Development
- Stability Storage
Avomeen’s Pharmaceutical Facility
Avomeen’s fully-equipped CTM analysis and testing lab includes:
- 25,000 Sq. Ft. State-of-Art Laboratory
- cGMP laboratories equipped with state of the art analytical instrumentation for analytical support
- Dedicated laboratory for manufacturing
- Compounding/formulation suites
- ISO Compliant Clean Rooms
- FDA-Registered, cGMP-Compliant, DEA-Licensed (Class I-V)
Avomeen supports clinical trial material manufacturing in support of Phase I-2a development. In addition to offering packaging and labeling on the products we manufacture on your behalf, we can perform over-encapsulation to formulate and manufacture matching placebos for your comparative studies.
Once the formulation process development is complete, we can scale-up manufacturing processes and perform a technology transfer to your facility or a third-party site.
- Method Development & Validation
- Extractables & Leachables Analysis
- Stability & Release Testing
- Chemical Characterization Testing
- Pre-Formulation & Formulation
- Process Qualification & Cleaning Validation
- Process Operations Optimization
- Analytical Development Support
- Quality Control Testing
- Litigation Support Services