CELLSCRIPT

Since 1987, Polymer Solutions (PSI) has been answering difficult questions regarding polymers, plastics, metallic materials, and composites. From our home in Christiansburg, Virginia, we partner with our clients from around the world to solve and prevent their most complex problems through chemical analysis, physical testing, and consultation.

We serve the Medical Device, Medical Product, Packaging, Pharmaceutical, Aerospace, Defense, Consumer Product, and Industrial Manufacturing industries.

Our laboratory capabilities include metals testing, microscopy, spectroscopy, physical testing, wet chemistry, titrations, liquid chromatography, and gas chromatography.

Some of the ways we frequently help our clients through polymer analysis, plastics testing, or other materials testing include:

• Method Development & Validation
• Failure and Corrosion Analysis
• Lot Release Testing
• Compositional Analysis
• Film Layer Analysis
• Extractable / Leachable Testing
• In Vitro Testing
• Residual moisture, monomers, solvents, and catalysts
• Level of Crystallinity
• Contamination Analysis
• Shelf-life Stability Tests


We are ISO-17025 accredited, cGMP compliant, FDA registered, and DEA Licensed.

Please don't hestitate to let us know how we can help you; email us at: Great.Science@PolymerSolutions.com
or visit our website, www.polymersolutions.com.

We help our clients advance their topical and transdermal drug programs all the way from product concept assessment through to first regulatory filing, or with one or more stages in between. Our parent company, Encube Ethicals, is a global leader in topical contract manufacturing services, operating the world’s largest single-site manufacturing site for such products. Together, Tioga Research and Encube Ethicals can support our clients from early formulation product innovation through to full-scale commercial manufacturing.
Clients regularly seek the support of Tioga Research for one or more of:
• Analytical method development & verification
• Pre-formulation (solubilities, compatibilities etc.)
• Formulation re-engineering (for delivery improvements and freedom to operate)
• Formulation innovation (for optimal performance & patentability)
• Skin delivery & permeation screening
• Broad-based screening of formulations using proprietary high throughput experimentation platforms (such as INSIGHT™, STORM™, TORNADO™ and SPLASH™)
• in vitro release testing (“IVRT”) & in vitro permeation testing (“IVPT”) under GLP conditions for release and bioequivalence support
• Formulation optimization
• Stability assessments
• Product esthetics assessment (sensory panels)
• Skin safety studies (employing third-party CRO)
• Patent application support
• Technology transfer
#TiogaResearch helps progress client programs intended for the spectrum of regulatory paths: #topical505b1, #transdermal505b1, #topical505b2, #transdermal505b2, 505(j) (or ANDA), 510(k) and PMA. We are particularly adept at creating high-performing formulations that have a robust basis for composition of matter patentability.
#TiogaResearch supports personal care and skin care companies by creating and deploying new measurement platforms, by information mining and text data aggregation, by innovating excipient packages, and by completing measurements of skin deposition, delivery and permeation.

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

Pharmaron is a contract research organization (CRO).

Services:
* Synthetic, medicinal and analytical chemistry services
* Biology services
* DMPK services
* Pharmacology services
* Drug safety assessment services
* Radiochemistry and isotopically labelled metabolism services
* Chemical & pharmaceutical development services
* Clinical development services

www.pharmaron.com

CRO - Contract Research Organization
Library Synthesis
CADD
Bioorganic Chemistry
Discovery Process Chemistry
Radiolabelled Chemical Synthesis
ChemInformatics
in vitro Biology
in vitro Screening
Structural Biology
in vivo Pharmacology
Animal Disease Models
ex vivo Pharmacology
Biomarkers
in vitro ADME
in vivo PK
PKPD
QA
Regulatory Affairs
Discovery Biologics
Process Chemistry
API Manufacturing
Material Science
Formulation Development
Drug Product Manufacturing
Toxicology
Safety Pharmacology
Genetic Toxicology
DART
Pathology
Immunotoxicity
Bioanalytical
14C / Carbon-14 Radiosynthesis
3H / Tritium Radiosynthesis
QWBA
mARG
Clinical AME
Mass Balance
Metabolite Profiling
Microdosing Phase 0
Absolute Bioavailability
DDI
First-in-Human (FIH)
Thorough QT(TQT)
Ethnobridging

BioDuro is a global provider of contract research, development and manufacturing outsourcing solutions. Pharmaceutical, biotechnology and virtual companies are offered a comprehensive array of scientific services spanning the drug discovery and development continuum. Our precise balance of scientific rigor and flexibility enables fast, informed decision-making and maximizes the chances of success at every stage of any project.

From a complete understanding of project objectives at inception, to timeliness on all high quality deliverables, we work with our customers as true partners to create new efficiencies, ideas and innovation. Our unique organizational culture is based on empowerment, respect for diversity, recognition and cooperation. Our customers are part of the extended BioDuro family, ensuring an exceptional customer experience and our constant pursuit of your success.

For more information about BioDuro, please visit our website at www.bioduro.com.

Since 1979 Aalto Scientific has been a leader in the manufacture and supply of private label/OEM control and calibrator sera, purified HUMAN proteins, and bulk processed HUMAN and ANIMAL sera to the worldwide in vitro diagnostics (IVD) manufacturing community.