Industry-Leading Technical and Regulatory Expertise
Pharma and biopharma companies trust Avomeen’s industry-leading technical and regulatory experts to support them from a therapeutic concept to market and beyond. Our blend of unmatched scientific expertise and one-of-a-kind capabilities ensures that your biopharma and therapeutic products move smoothly through the development life cycle.
Our Pharmaceutical Analysis Testing
Biologics Analysis – Biologics now represent a major class of modern therapeutics and their importance only continues to grow as new modalities, drug targets, and therapeutic mechanisms emerge. Our team of biopharmaceutical experts can help support your biologic in all stages of research and development: from early discovery through IND, BLA, and beyond. Among our service strengths, Avomeen can rapidly design, develop, and execute biologic analysis methods for regulatory submissions and release testing for a wide variety of modalities.
Biomarker & Bioanalytical Testing Services – As we progress further into this new age of precision medicine, ground-breaking therapeutics benefit from more refined and thorough bioanalytics that better evaluate efficacy and ensure patient safety. Avomeen offers a full suite of bioanalytical testing services, from high-throughput clinical sample bioanalysis, biomarker method development services, DMPK/ADME studies, toxicity assessments, and more.
CMC – Chemistry, Manufacturing and Controls (CMC) not only is in the creation and development of a new product, but in all other stages of the products lifecycle. Avomeen’s expertise extends through many CMC services including extractables and leachables, solid state characterization, stability testing, and beyond. The combination of specialized analytical instrumentation and our industry leading scientists allows us to think big and bring your products to market, no matter how challenging it may be.
Formulation & GMP Manufacturing – Avomeen has years of experience developing formulations and manufacturing both clinical and commercial products. Our chemists and pharmaceutical scientists have experience handling controlled substances and can manufacture most dosage forms and drug delivery systems including solid and oral medications, topical treatments, OTC medications, suppositories, transdermals, and more. If you’re interested in partnering on product development and/or manufacturing, connect with us to find out more about our capabilities.
Chemical & Material Sciences – From analytical testing and deformulation to failure analysis and impurities identification, Avomeen’s multi-disciplinary chemists have the know-how to help with your scientific business challenges. Our team can improve existing methods, propose new methods, detect and identify contaminants and deformulate and/or reformulate various formulas.
Safety, Legal & Regulatory – Avomeen’s expertise is not limited to formulation, manufacturing and method development. We are more than a full-service contract laboratory. Our expert analytical scientists have experience in safety and regulatory testing in addition to providing expert witness testimony within a variety of industries and regulatory standards.
Pharmaceutical Testing Lab Capabilities
We work with our partners to build comprehensive programs that incorporate the assays, methods, and instruments that will best help them to reach their goals. This may include:
- Therapeutic Peptide Analysis
- Therapeutic Protein Characterization
- Monoclonal Antibody Characterization
- Gene Therapy Analytical Testing
- Cell Culture & Bioassay Services
Chemistry, Manufacturing & Controls (CMC)
Chemical & Material Sciences
Formulation & Product Development
- Formulation & Process Development
- cGMP Clinical Trial Material Manufacturing
- Small Batch Manufacturing
Safety, Legal & Regulatory
- Agilent HPLC
- Agilent HPLC with DAD and Thermo-ESA Corona Charged Aerosol Detector
- Agilent HPLC with DAD and Polymer Labs PL/ELS ELSD
- UPLC with DAD & Fraction Collector
- Agilent GC-FID/TCD
- Agilent GC-MS/FID with Headspace Autosampler
- Ion Chromatography System
- Dionex Integrion RFIC System
- Waters Acquity UPLC with Xevo G2-S Quadrupole Time of Flight (QTOF)
- Thermo Finnigan LCQ Deca LC-MS
- Sciex HPLC + API LC-MS/MS
- Maldi Micro MX Mass Spectrometer
- Agilent Inductively Coupled Plasma Mass Spectrometer
- Agilent ICP-MS
- AB Sciex Triple Quadrupole API Mass Spectrometers
Other Capital Instrumentation
- Evolution Dissolution Apparatus Systems
- Protein Simple Maurice Capillary Electrophoresis (CE)
- Perkin Elmer Spectrum FT-IR
- ci4200 Spectrophotometer/ Colorimeter
- BioTek Epoch Microplate Reader
- Invitrogen Countess II Automated Cell Counter
- NANODROP UV-Vis Spectrophotometer
- Advanced® Micro-Osmometer
- Karl Fischer Titrators
- TA Instruments Differential Scanning Calorimetry
- TA Instruments TGA
- Sievers Laboratory TOC Analyzer
- Brookhaven ZetaPALS Zetasizer
- Malvern Mastersizer
- Franz Vertical Diffusion Cells Apparatus
- Caron Stability Chambers (Custom Settings)
Comprehensive Solutions for a Variety of Drug Products
Generic Drugs – We understand generic drug development requires a strong CRO/CDMO. Avomeen always delivers high quality, efficient and regulatory compliant analyses at each and every step of the drug development process. Avomeen has experience in Q1/Q2 (Q3) deformulation and will work with you through each stage of development ensuring your products safety and stability for ANDA filings. Our Ph.D. scientists’ support you from early R&D work to ANDA submission and beyond, even in post-market stages.
Innovative Products – Our talented and dedicated scientists are uniquely qualified to formulate improved, novel and National Brand Equivalent (NBE) products in addition to meeting full cGMP and monograph requirements. Avomeen is experienced in handling new chemical entities (NCE’s) from R&D stage to clinical phase I and Phase II stages. Avomeen has successfully executed multiple NCE’s from preformulation to clinical stages with short turnaround time and high quality results.
Biologic Drugs – Advancements in biotechnology continue to open new avenues in biopharmaceutical discovery and development. Understanding the unique challenges posed by biologic drugs, Avomeen’s highly experienced biopharma experts have the skillsets needed to fully investigate your biologic’s potential and help you realize it.
Combination Products – In developing combination products, it’s important to understand the components in the context of the combination and the unique challenges that may arise as these challenges often reach beyond traditional drug development. Avomeen’s Ph.D.-led teams of scientists have expertise and pharmaceutical knowledge to deliver the data you will need to reach the next step with your combination product while adhering to current regulatory and quality standards.
OTC Drugs – No matter the type of OTC product you are developing, Avomeen has the extensive FDA and EPA regulatory knowledge to help with the various challenges when getting to market. Our Ph.D. scientists will work with you, addressing every concern from labeling and packaging to product use, delivery methods, potency, safety and effectiveness.
Support Throughout the Entire Drug Development Lifecycle
Developing a new, potentially life-saving drug is a time consuming and financially intensive endeavor. There is simply no room to miss something along the way. Avomeen provides full support to biopharmaceutical companies throughout the drug development process to ensure regulatory standards and requirements are met.When you’re developing a drug, we’re with you every step of the way. Learn how we stand by your side during each phase of the development process.
Discovery –During the discovery phase, we offer characterization, method development, and method qualification assistance.
Preclinical –Through dose verification and continuing method qualification, we help you get your product ready for clinical trials.
Clinical Trials –During the clinical trials phase, we measure clinical stability, test raw materials, offer facilities and process validation, and perform method validation.
Review, Approval & Post-Approval –Our services support your development through the provision of scientifically sound data to verify safety, effectiveness, and controls.
Avomeen’s full support programs are designed to see your drug development from inception to the post-approval phase. Benefit from the assistance we provide to meet the many regulatory requirements imposed on drug manufacturers throughout the approval lifecycle.
Why Partner with Avomeen’s Pharmaceutical Testing Labs?
Avomeen’s decades of industry experience and numerous Ph.D. scientists ensure we meet your project needs and exceed your expectations. Here are some of the benefits of partnering with us:
- cGMP compliant, FDA registered, DEA licensed
- Consultative, flexible, and responsive staff
- Project customization to your specific needs
- Experience in solving difficult analytical and formulation challenges
- Delivery within tight timelines
- Up-to-date regulatory knowledge to ensure compliance
See how our pharmaceutical testing services can transform your boldest goals into real solutions.