Avid Bioservices

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

Haematologic Technologies (HT) is a large molecule CRO unlike any other. Combining world-class protein chemistry expertise, integrated large molecule analytical services, and customized products to support biopharma R&D, we accelerate large molecule drug development for clients around the globe.

HT’s services are offered from discovery through commercial GMP release of large molecule therapeutics. Not your typical large molecule CRO, HT has a specific depth of expertise in large molecule analytics, manufacturing process support, and navigation of the complex regulatory pathways from IND to BLA. Our services de-risk and speed your new drug development process.

Our scientific experts are well known in the fields of protein chemistry, advanced High Resolution Mass Spec (HRMS), Immunology, hemostasis, and novel assays to support complex large molecule therapeutic development and manufacture. Our FDA-inspected facilities operate to the highest standards of GMP compliance.

Building on our 30+ years of expertise in plasma proteins, hemostasis and blood coagulation, HT is also a leading global supplier of coagulation research reagents (plasma proteins and antibodies), custom formulated IVD/POC device reagents, as well as customized blood collection tubes to support clinical trials.

Visit us at www.haemtech.com.

Smart Consulting Group provides technical and regulatory compliance support for biotechnology, medical devices, pharmaceuticals, vaccines, and specialty products, solving complex challenges for both the industry and governments.

We provide advisory and support services in a broad range of categories, including but not limited to:

• FDA Regulatory Compliance
• Quality Systems Design and Implementation
• Forensic Analysis for Data Integrity
• GMP, GLP, and GCP Audits
• Assessments and benchmarking
• Compliance and Quality Risk Assessment
• Regulatory Strategy
• Product/Process Development/Manufacturing
• Laboratory Compliance and Operations Analysis
• Documentation Management Support
• Project Management
• Technology Transfer Strategy and Oversight
• Staffing support for highly specialized talent
• Support services to facilitate organizational change

Smart Consulting Group has expertise in solid dosage forms, parenteral pharmaceuticals, a wide range of biological products, vaccines, recombinant products, monoclonal antibodies, cell therapies, tissue-engineered products, and device-combo products.

When it comes to understanding the physical structure, chemical properties and performance of advanced materials and integrated circuitry, no other scientific services company offers the breadth of experience, diversity of analytical techniques or technical ingenuity of EAG Laboratories. We deliver multi-disciplinary, problem-solving expertise to help our customers accelerate innovation, ensure quality and safety, and protect intellectual property.

The world is experiencing a powerful and rapid convergence of science, technology and commerce. Great scientific minds are driving awe-inspiring commercial initiatives, and companies around the globe are seeking the insight and competitive advantage that advanced science can provide. EAG is at the forefront of this revolution–one that is changing the way products are developed, designed, manufactured and used by millions of people around the planet.

Whether you are seeking to speed time-to-market, solve manufacturing problems or ensure regulatory compliance, turn to EAG. We know how to bring the power of science to every phase of your product lifecycle.

* Product Innovation & Improvement
* Investigations & Troubleshooting
* Quality Assurance & Quality Control
* Regulatory Compliance
* Consulting & Litigation Support
* Manufacturing/Supply Chain Support

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