MedChem Partners

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

BioChroma Analytical Labs LLC is based out of the DFW metroplex in the heart of Texas. It was created to fill the technical gaps in new product development for innovators with new ideas that might not have all the necessary components to make it happen and to offer support for product quality through analytical testing and consulting. We provide an all-encompassing service to help our clients develop a product that is continually manufactured to the level of quality customers expect. Our goal is to provide continual scientific and technical support for entrepreneurs and established businesses based on quality at an affordable price. We are here to provide technical assistance to foster their idea from inception to the marketplace and beyond.
We have experience and expertise in research and development, formulations, scale-up, testing, quality and regulatory of a wide variety of consumer products in the areas of cosmetics, skin care, topical and oral OTCs, food, beverages, dietary supplements, household cleaners and the like.

Product Research and Development: Skin, Body, Hair Care Development, Dietary Supplement Development

Consulting: Packaging Advice, Manufacturing Advice, Plant Inspections, Ingredient Stability Advice, Container Closure Advice, Product Formulation Advice, Quality and Regulatory Advice

Chemistry Analysis: Nutritional Analysis, Mineral Analysis, Vitamin Analysis, Preservative Analysis, Active Ingredient Analysis, Allergen Analysis

Microbiological Analysis: General Microbiology Analysis, Pathogenic Bacteria Analysis, Spoilage Organism Analysis, Preservative Efficacy Analysis, Bacterial Challenge Studies, In vitro Time-Kill Studies, Antibiotic Studies, Water Suitability Testing

Laboratory Research and Development: Transdermal Studies, Antimicrobial Efficacy, Product Specific Studies Aimed at Demonstrating Efficacy or Quality

Afraxis Inc. is a contract research organization (CRO) specializing in:

- CNS preclinical efficacy evaluations (in vivo & in vitro)
- Neurotoxicity evaluations
- Structure-Efficacy Relationship (SER) medicinal chemistry

The patented Afraxis ESP (Enhanced Spine Platform) technology produces a rapid, high-information read-out of synaptic networks from whole brain or other tissue preparations. The process incorporates (a) specialized labeling of individual neurons, (b) laser-scanning microscopy, (c) rapid and high-detail morphometry of individual synapses, and (d) novel powerful statistical methods tailored for big data analyses.

The Afraxis ESP platform was first developed within the original Afraxis, Inc. (now Afraxis Holdings), a company founded in 2007 to develop novel therapeutics for Fragile-X Syndrome (FXS) based on the work of Nobel laureate Susumu Tonegawa. The ESP technology was developed originally to solve an unmet need in Fragile-X drug discovery: the lack of a rapid tool to evaluate test compounds against dendritic spine abnormalities, the hallmark neuorbiological phenotype of FXS observed in both humans and rodent models. Considering the broad reach of dendritic spine abnormalitiies throughout CNS diseases, the tool was immediately applicable for other indications. The current Afraxis, Inc. was founded in April 2013 as a spin-out company by Christopher Rex and Carmine Stengone to develop the core ESP technology and drug discovery services.

I manage the Drug Product Manufacturing and Discovery Biology for Archer CPS. I serve multiple roles in Archer’s drug discovery, manufacturing and analytical work. My experience ranges from industrial to academic to non-profit environments, working in several fields including Chemistry, Biochemistry, Structural Biology and Drug Formulation. I have developed several immediate and modified release formulations of novel therapeutics and has completed Phase I manufacture of drug product in support of regulatory filings for Archer. I am actively engaged in collaborative efforts with Archer biologists to screen and validate novel drug compounds and targets in addition to overseeing drug formulation, manufacture, and analysis. I have developed many methods for small molecule isolation and characterization for drug discovery, as well as conventional quality control tests required for drug substance and drug product release and stability. I work closely with Archer CPS's Quality Services group in the preparation of the CMC sections for IND and IMPD submissions.

Avrio Biopharmaceuticals is dedicated to providing our clients with high quality, flexible and on time clinical trial material manufacturing services. Our experienced and dedicated staff and our world class facility allow us to provide our clients with timely solutions to meet the demand of early phase clinical trial material manufacturing.

Our newly commissioned, cGMP manufacturing facility offers a full range of services for your clinical trial material production.

Range of cGMP Support Services
Pre-formulation and Formulation Development
Small Molecules
Biopharmaceuticals

Parenteral Fill and Finish Manufacturing
Lyophilization
Blinding and Over-encapsulation
Packaging and Labeling
Regulatory Document Preparation
CMC Support
Clinical Supply Management
Complete Clinical Trial Support
Strategic Clinical Program Management
Clinical Protocol Development
Investigator Recruitment and Qualification
Clinical Study Management, Trial Monitoring and Data Analysis Preparation of Final Regulatory Submissions