Clinical Trial Materials (CTM Phase I – IIa)

cGMP Pharmaceutical Manufacturing – GMP Clinical Supplies

Our full-service drug development laboratory can take your product from initial development through clinical trials and into registration. We can also help with commercialization and post-approval drug development and testing support. We maintain experienced chemists and can solve even the most complex problems that can arise in the drug development process. We provide clinical trial material manufacturing services for phase I-IIb oral and topical pharmaceutical products.

Clinical Trial Manufacturing Services for:

  • Solid Dosage Forms (Tablets & Capsules, including Coated & Matrix)
  • Non-Sterile Liquid & Suspension Products
  • Semi-Solid Products (Creams, Gels, Ointments, Lotions, Pastes, Powder & Bead Filled)
  • Aerosols
  • Topical/Transdermal
  • Suppositories
  • Drug Substances
  • Powders (Bottled & in capsules)
  • Over-encapsulation
  • Packaging Analysis

Production Processes Include:

  • Blending/Homogenization
  • Filtration, Granulation, Compacting, Mixing, and Filling
  • Milling
  • Spray Drying
  • Pellet (Bead) & Powder Encapsulation
  • Powder Blending & Tableting
  • Liquid & Cream Manufacturing
  • Container/Closure Selection
  • Scale-Up & Technology-Transfer

These services include:

  • Trial Batch Manufacturing
  • Placebo Development
  • Packaging
  • Stability Storage

Avomeen’s Pharmaceutical Facility:

  • 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
  • More than 50% of staff is Masters, Ph.D., or above
  • FDA-Registered, cGMP-Compliant, DEA-Licensed (Class I-V), ISO 17025-Accredited

Your dedicated team of chemists will help you move quickly and efficiently from preclinical testing into clinical development. Avomeen supports clinical trial material manufacturing in support of Phase I-2a development.  We also offer packaging and labeling on all of the products we manufacture on your behalf into blister packs, bottles, tubes, and more. We can perform over-encapsulation developing matching placebos that we will formulate and manufacture for your comparative studies.  Once your formulations process development is complete, we can scale-up the manufacturing process utilized and perform a technology transfer to your facility or a third party site.

We are experts at solving the complex problems that can arise during the development process, and our full-service pharmaceutical development laboratory can support you in all stages of your drug development process include:

  • Method Development & Validation
  • Extractables & Leachables Analysis
  • Stability & Release Testing
  • Chemical Characterization Testing
  • Pre-Formulation & Formulation
  • Process Qualification & Cleaning Verification
  • Process Operations Optimization
  • Analytical Development Support
  • Litigation Support Services
  • Quality Control Testing

Avomeen chemists customize all of our projects to ensure that your individual needs are meeting. We offer detailed communications with your dedicated team of chemists and can work within your tight deadlines.

Contract Avomeen to arrange a free initial consultation with one of our Ph.D. chemists