CIMA 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

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

BIONEEDS INDIA PRIVATE LIMITED is a Bangalore based Contract Research Organization providing Integrated Discovery, Development and Regulatory Services to Pharmaceutical,
Biopharmaceutical, Agrochemical, Industrial chemical, Herbal/Nutraceutical and Medical device companies.

Accreditation/Certifications
• National GLP Compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Government of India
• Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Ministry of Environment, Forests and Climate Change, GOI.
• State Drug Controller as a Government approved Drug Testing Laboratory for carrying out tests on Drugs / Cosmetics and
• Raw Materials used in their manufacture on behalf of licensees for manufacture for sale of drugs / cosmetics
• Review Committee on Genetic Manipulation (RCGM), department of biotechnology, GOI to conduct experiments on animals for DNA or Genetically modied resources
• Bioneeds is AAALAC certified for laboratory animal care
• Bioneeds’ in-house R & D unit is recognised by Department of Scientic and Industrial Research (DSIR)
• ISO 17025 certified for Biological evaluation of Medical Devices
• Bioneeds has best-in-class infrastructure equipped with state-of-the-art facilities with 2,50,000 sqft built-up area.
• Vivarium with 85 exclusive animal rooms built as per international standards
• Cutting edge Drug Discovery and Development Labs to support Medicinal chemistry, Biology, In vivo Pharmacology,
• Toxicology, Custom synthesis, Process R&D, cGMP manufacturing, Formulation and Analytical development services

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

Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented Pharma Company with presence in 55 countries. Indoco, a USD 166 million company, employs over 6000 people including over 300 skilled scientists.

The Company has 9 manufacturing facilities, 6 for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by various regulatory authorities such as USFDA, UK-MHRA, DRU Botswana, PMDA-Japan, TGA-Australia, FMHACA-Ethiopia, DPML- Ivory Coast, SAHPRA- South Africa, NDA-Uganda, etc.

Indoco has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals,  Cardiovascular, Anti-Diabetics, Pain Management  etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital,  Sensoform, Sensodent-KF, Cloben-G, Glychek, Kidodent, Carmicide, Rexidin, MCBM, Methycal, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.

Indoco has carved a place for itself in the international arena and is exporting a number of generic products in the Regulated and Emerging Markets. Indoco’s branded formulations are promoted in Emerging Markets of South East Asia, Africa, Latin America and CIS countries. The Company participates in various tenders floated by authorities from different countries. Indoco has tie-ups with large generic companies across the globe and works in close coordination with its customers for leveraging core competencies.

Indoco Analytical Solutions division has been carved to serve customers for their analytical research needs. AnaCipher CRO, Hyderabad, is a USFDA inspected facility providing clinical trial solutions, BA/BE/Phase I/Phase studies.