cGMP Biopharmaceutical Laboratory

Analytical Testing and Product Development Services – Small Molecules and Biologics

Avomeen brings years of analytical testing experience to small and mid-size biopharmaceutical companies progressing drug products from pre-IND through Phase II-a clinical studies.  Drawing on our technical staff members experience gained from their time working within pharmaceutical companies, Avomeen chemists are a true extension of your organization providing personal guidance each step of the way to approval.  Our staff together with a fully outfitted laboratory are up-to-date on technology, industry guidance, and regulatory requirements so you can concentrate your efforts on the other aspects of launching a drug product.

FDA-Registered, DEA-Licensed (Schedule I-V), cGMP-Compliant, and ISO/IEC 17025-Accredited

From method development & validation to producing clinical supplies, to the identification and quantitation of complex impurities and degradation products; our full-service laboratory has the analytical instrumentation, techniques, and expertise required to complete your project on time and on-budget.  Call 800-930-5450 for consultation with one of our talented scientists.


Candidate to Clinic – The Fastest Route

Our clients come to Avomeen for our technology and problem-solving expertise and stay with Avomeen for our regulatory knowledge experience, turnaround time, and on-time-delivery (OTD)


Drug Development Process

The drug development process starts with basic research & discovery followed by screening, candidate selection, and an IND Application.  Once the lead candidate is selected the pharmaceutical product moves into Avomeen’s area of expertise: preclinical development & IND-enablement through Phase IIa clinical trial material manufacturing and post-market testing services.

Let the drug development experts at Avomeen accelerate your product’s path to market.


Specialties Include

 

Pre-IND through Phase II-a Clinical Studies

  • Pre-Formulation Studies
    • Solid State Characterization
    • Polymorph Screen
    • Excipient Compatibility
  • Dosage Form Selection
  • Analytical Method Development & Qualification
  • Process Impurities Analysis
  • Phase I – Clinical Supplies
  • Phase I – Stability Analysis
  • Formulation Development/Optimization
    • Process Development
  • Analytical Method Development
  • Analytical Method Validation
  • In-Vitro Release and Dissolution Testing, Product Performance Metrics
  • Reference Standard Characterization
  • Phase II – Stability Services
  • Phase II – Clinical Materials Manufacturing
  • Raw Material Sourcing
  • Scale-Up Studies
  • Phase III Clinical Materials Manufacturing
  • Packaging & Labeling
    • Extractables & Leachables
  • Analytical Testing
  • Stability Services

New Drug Application (NDA/BLA)

  • Formulation
  • In-Vitro Release
  • Commercial Supplies
  • Container Closure Selection
  • Registration Stability
  • Excipient Compatibility
  • Extractables & Leachables Studies

Related Services

  • Parallel Pathway with some additional requirements
    • Biosimilars
    • Proteomics
Types of Products

  • Small Molecules
  • Over the Counter (OTC)

Primary Services

  • Q1/Q2 (Q3) Deformulation
  • In-Vitro Release Testing
  • Method Development & Validation
  • Extractables & Leachables
  • Reference Standards
  • Registration Stability  
  • Formula Reproduction
  • Scale-Up Support
  • Tech-Transfer

Avomeen can solve your most complex pharmaceutical challenges:

  • How do I navigate the drug development and FDA regulatory approval process?
  • What is the best dosage form for my API?
  • Who can develop precise and accurate validated analytical methods?
  • What is the source of product contamination?
  • What is the stability of my finished product?

Our analytical investigations provide fast and reliable answers to your toughest problems.  See some of our case studies:


Avomeen scientists will customize methods and processes to your needs and are current with the most sophisticated instrumentation and equipment, techniques, and technical developments in the industry.  Our analytical investigations provide fast and reliable answers to your toughest problems.

Why Use Avomeen for Your Pharmaceutical Development Needs?

  • Direct Consultation with Ph.D. Level Chemist
    • Responsive Staff who are Flexible to Your Needs
  • Rapid Turnaround on Requests for Proposal (RFP)
    • Project Customization (No Cookie Cutter Quotes)
  • Wealth of Knowledge & Technical Expertise
    • Experience in Solving Difficult Analytical & Formulation Projects
  • We Will Work Within Your Tight Deadlines
    • High-quality results on-time and within budget
  • Our Regulatory Knowledge Can Help Keep your Product in Compliance

For More Information or to Request a Proposal

Click Here to Request A Pharmaceutical Development Quote (RFP)
Email: scientist@avomeen.com
Call: 1-800-930-5450