assa international 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

Ceutical Laboratories provides services to the pharmaceutical, medical device, dietary supplement, veterinary, cosmetic, and food industries. Ceutical Labs provides formulation development, design development, project management, process development, analytical testing (chemistry, microbiology, and physical testing), consulting, training, regulatory submissions (IND, NDA , ANDA, 510K, PMA, etc.), regulatory compliance, ESG submissions, quality system implementation, validation support, FDA management, auditing, IT solutions, and marketing expertise. YOUR SUCCESS is our goal.

Analytical testing equipment includes GC, GC/MS, HPLC, HPLC/MS, HPLC/MS/MS, ICP, AAS, XRF, Polarimeter, and much more. Our formation expertise includes Rx, solid dose, topicals, and parenterals. Our laboratory has over 50,000 square feet. Our training facility has over 10,000 square feet. We will meet and exceed your expectations.

We seek to help our customers achieve regulatory compliance. Our customers who have fully implemented our quality systems have received very few to no observations. We are routinely inspected by US FDA and Health Canada. Our goal is to remain compliant. We are a third party sampling and testing laboratory for US FDA.

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

US-PHARMASERVE INC. is an outsourcing, program management and consulting group specializing in research, process design & development, pre-clinical work up, and the cGMP production of biologics for the Phases I & II clinical trials, as well as ISO-9001 manufacturing of diagnostic reagents and kits.
We have significant in-house expertise and ready access to an impressive network of over 300 world-class subject matter experts, freelance consultants, sub-contractor, vendors and service providers to outsource and manage your projects.
Our business model encourages and fosters participatory decision making by our clients.
Our Mission:
To custom design and execute the best-in-class outsourcing solutions for our clients so that their programs and products are completed and delivered:
On their timeline,within their budget,meeting their final product specifications with the quality they expect
Achieving compliance with cGMP, ISO, or other regulatory guidelines'​
We outsource and manage your projects in the following areas:
Process Design, Development, R&D and Preclinical Work-up
cGMP Clinical Trials Material Manufacturing and sterile liquid fill finish
Formulation development and Stability Studies
Safety Studies
. Marketability studies.
Management consultation (due diligence, valuation, strategy, restructuring, and financial transactions), scouting for seed and early stage venture funding.
Medical and technical writing and editorials

Amarex is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services.

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