Afraxis, Inc

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

NCGS, Incorporated is a full-service international CRO managing clinical trials since 1984 in drug, biologic, device, diagnostics and consumer products. NCGS provides full-service or strategic sourcing needs focused on risk mitigation. Contingency planning is actively employed, not just planned for. NCGS is a WBENC certified diversity supplier.

NCGS has supported the development or expanded labeling of 78 approved products and has ZERO 483s.
NCGS clinical teams are first in class, highly- tenured professionals
- 10+ years’ experience; A team remains throughout the trial
- Turnover rates are discernibly different at less than 3% annually

CLINICAL TRIAL THERAPEUTIC FOCUS INCLUDES:
- Neuro-Psych (CNS)
- Infectious Diseases / Critical Care
- Oncology, hematology, transplant
- Trials in multiple other areas have been conducted

ROBUST DIVISION OF COMPLIANCE & RECRUITMENT SPECIALIST
- CAPA initiatives
- Due diligence auditing
- eTMF
- Subject recruitment
- Call Center 24/7
- Trial Rescue
- Safety, SAE narratives and SAE reconciliation

FULL SERVICES INCLUDE:
• Clinical Operations and Monitoring
• Fully Integrated e-Based iCloud Systems
- e-REMOTE: Risk-based monitoring
- eTMF: TMF Migration, Consolidation
- ePAY: Grants, Contracts, Payments
- eDM: EDC, IWRS
- ePRO:Patient Reported Outcomes
- eCLIN: CTMS
• Medical Monitoring & Clinical Safety
• Quality Assurance & Regulatory Compliance
• Global Strategic Sourcing
• Medical Writing
• Biostatistics

STATKING Clinical Services (SCS) is proud of its 30 year history of service to emerging pharmaceutical and medical device clients. Since the company's founding in 1989, the company has evolved from providing statistical consulting and data analysis services on a variety of household products to a full service Contract Research Organization (CRO) serving the pharmaceutical and medical device industries.

Today, the company employs a staff of product development specialists that are heavily involved in all phases of the Client's development program including protocol development, medical monitoring and clinical trial management. STATKING's highly experienced team of professionals has been instrumental in achieving regulatory approval for a number of new medical devices, drugs and biologics. At STATKING, our team is committed to providing services that meet or exceed all Federal Guidelines and Regulations for Good Clinical Practice.

Service Areas:
Protocol Development, Clinical Trial Management, Medical Monitoring, Clinical Study Monitoring, Medical Writing, Regulatory Submissions, Biostatistics, SAS Programming, Clinical Data Management and Safety Monitoring.

Therapeutic Areas:
Radiopharmaceuticals, Diagnostics, Oncology, CNS, Women's Health, GI, Orthopedic and Bone, Cardiac, Pain Management

AfaSci, Inc., a San Francisco Bay Area biotech company committed to enhancing health care by conducting R&D in both Biotechnology and Therapeutics. Our bioengineering team has designed, produced and been marketing an in vivo drug screening platform, SmartCageTM. This system enables automated, and objective assessment of drug effects on rodent behavior and increases throughput of phenotyping of transgenic animals. Elevating our proprietary platform and well-established electrophysiological techniques, AfaSci’s scientists have been discovering IND drug candidates targeting ion channels and GPCR for the treatment of CNS disorders, especially neuropathic pain, epilepsy and Alzheimer’s disease.

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