BioChroma Analytical Labs

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

MedChem Partners is a medicinal chemistry CRO founded in 2006 by Tsvetelina Lazarova and Steven Riesinger. The company is focused on using the extensive experience in early stage company formation and drug discovery to effectively advance small molecule candidates for clients by working closely with the client’s biology and/or chemistry resources. Our experts have extensive experience in moving projects from inception through discovery and into development up to IND enabling toxicology.

At MedChem Partners, we are experts at using synthetic and medicinal chemistry to develop small molecule therapeutics. Unlike large one-stop shops that spread their attention over a variety of tasks, we focus on what we know best. Our expertise is in formulating and implementing a plan to find and optimize small molecules which interact with novel or known biological targets. Whether you already have potential molecules in mind, or have just discovered a novel target, we can develop a plan to find and optimize compounds with therapeutic potential. Since drug discovery is a multidisciplinary endeavor, we have foraged close contacts with a variety of other service providers to augment our expertise in certain areas. Since each company is focused on what it does best, this approach allows us to tap into the best talent in each area. Through out network we have access to in vitro and in vivo testing, in vitro and in vivo pharmacokinetics, computer modeling and in silico prediction, formulation, scale-up and manufacturing, toxicology and regulatory filing, x-ray crystallography, intellectual property and patenting, and consultants in clinical, regulatory, manufacturing, pharmacology, and toxicology.

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

Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:

Consulting
• CMC Project Management
• GMP Auditing
• Licensing
• Sourcing & Procurement

Drug Discovery
• Medicinal Chemistry

R&D/Pre-Clinical
• Analytical Method Development
• Catalysis Screening
• Crystallization
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities

Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing

Chemistry Technology Platforms
Aseptic Fill & Finish
• Chlorination
• Chromatography
• Cryogenic
• Distillation
• Fermentation
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Hydrogenation
• Lyophilization
• Nitration
• Pastillation
• Phosgenation
• Polymorph Screening
• Powder Filling
• X-ray Crystallography

Project Examples
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier

Industrial Microbiological
Laboratories, Inc. has offered
Microbiological testing services to a wide variety of industries since 1984.

Industrial Microbiological
Laboratories, Inc. Is certified by the
State of Tennessee for the analysis of potable drinking waters, and is certified
by SBA as a minority (woman) owned
business. IML, Inc. can assist in the development of a complete
microbiological evaluation program
from raw materials through finished
product analysis.

Our team of experienced
microbiologists is dedicated to
providing the highest level of quality and service. We guarantee an experienced microbiologist will initiate your tests on the date of arrival.

Industrial Microbiological
Laboratories, Inc. assists clients in
total quality management of
production standards, adhering to
strict manufacturing and regulatory specifications.

TESTS PERFORMED:

MICROBIOLOGY

Standard Plate Count
Coliform (VRBA)
Coliform MPN.
E. Coli MPN
E. Coli 0157:H7
Enterobacteriaceae
Group D
Streptococcus
Yeast and Mold
Staphylococcus Aureus
(Coagulase Positive)
Salmonella
Rope Spore Count
Mesophilic Sporeforming Aerobes
Anaerobes
Bacillus Cereus
Clostridium Perfringens
Listeria Monocytogenes
Flat Sour Spores
Total Thermophilic Spores
Total or Fecal Coliform
(Membrane Filtration)
Campylobacter
Lactobacillus
Aerobic Plate Count (USP 35)
Yeast & Mold (USP 35)……………………….

MYCOTOXINS

Aflatoxin
Vomitoxin
T2 Toxin
Zearalenone
Aflatoxin M1
Sulfamethazine