BioLink Life Sciences

Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated Contract Research Organisation (CRO) services provider offering its expertise in Custom synthesis (Reference standards, Impurities, Metabolites, Deuterated compounds and Phyto standards), Analytical research (PH Buffer Solutions, Method development, Validation), Stability studies, Formulation & Development (New Drug Delivery System), Quality assurance and Regulatory services with a right blend of competent people, state of the art infrastructure facilities, cutting-edge technology and certified processes to pump your development pipeline with time and cost advantages.

Our expertise will also enable you to combat in the highly competitive markets and also in acquiring the niche segments. We desire to be your strategic partner for outsourcing and help you right from strategic planning of CMC blue-print to accelerating the filing and representation for NDAs and ANDAs submitted in any regulated and semi-regulated markets which can reduce your time and efforts for focusing them in your core areas of operations.

Since its inception in 2001, Pharmaffiliates has been serving customers across the globe comprising major Pharmaceutical companies, API manufacturers, Bulk drug suppliers, clinical CROs and other allied industries. Pharmaffiliates comes up with ISO certified ISO 9001:2008. Our effectiveness in successful service delivery has had its origin in our endeavor to carry out projects efficiently, on time and at a reasonable cost.

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

GEM FORLAB gives continuity to the experience of ABLE Biosciences as a global provider of scientific technology and services to the Life Science industry. It delivers solutions to companies of all size and shapes.
GEM FORLAB performs its activities by means of three technology areas:
Organic Chemistry
Mass Spectrometry & Proteomics
Cell and Molecular Biology & Immunoassay

ABLE Biosciences is the Test Facility GLP certified for small and large molecules quantitative analysis in biological matrices by means of Mass Spectrometry, Immunometric assays and qPCR and it is included in OsSC register of Private Laboratories qualified to perform analysis on samples derived from drug clinical trials (phase I-II-III) in compliance with GCP.

The Chemistry Unit provides all essential components for early drug discovery such as synthesis of chemical intermediates, process impurities, reference compounds, drug metabolites, and pro-drug; lead generation and optimization; bioconjugate chemistry; targeted molecules for MRI and others Molecular Imaging techniques.

API MANUFACTURING:
Apertus manufactures active pharmaceutical ingredients (APIs) for companies that make finished dosage products and/or develop novel dose delivery systems and formulations. Our focus is providing bulk (Schedule II–V) controlled actives, however non-controlled APIs are also within our project portfolio.

ANALYTICAL SERVICES:
Apertus performs analytical methods development and services on a variety of instrument platforms. Our primary focus is LC (UV), LCMS and GCMS. We can use existing methods or develop novel methods on a per-project basis. In addition, we can provide methods validation, impurity identification and tech transfer packages.

PHARMACEUTICAL SERVICES:
Apertus provides services for drug discovery and preclinical development on a kilo-lab scale. We can supply intermediates, specialty chemical synthesis, process optimization and scale-up services. In addition we can aid in characterizing RLDs via dissolution profiles, chemical analysis and microscopy. All services can be provided under cGMP if desired.

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