Colorcon®

CONTRACT RESEARCH ORGANIZATION

Norwich Clinical Services is a global Contract Research Organization (CRO) providing Clinical Research, Bioanalytical, Pharmacovigilance and Training Services.

The CRO is headquartered in Bangalore, INDIA and the leadership team have deep insight, knowledge and experience in the conduct of Bioavailability/Bioequivalence (BABE) studies, Clinical Research - Phase I-IV, Pharmacovigilance and Training services.

The NCS PV team manages >750 Molecules for the US, Europe, and APAC. We have call centers in the US and India.

Our facilities have been inspected by most global regulatory agencies such as FDA, WHO, ANVISA, MOH Turkey, EMA, DCGI and NPRA.

All our services are conducted in strict conformity with the latest GCP, GLP and 21 CFR (part 11) and all other applicable guidances.

We have state–of-the-art facilities, and exceptional expertise to conduct Phase I, II and III studies, bioavailability and bioequivalence studies, pharmacokinetic studies in patients & healthy subjects, drug metabolism studies, dose proportionality studies, multiple dose studies and clinical developmental programs. Our team has considerable experience in various dosage forms including parenterals, suspensions, topical preparations and delayed release formulations.

We combine comprehensive services and exceptional customer focus to offer a complete range of Clinical, Bioanalytical, Pharmacovigilance and Training Services.

Norwich Clinical Services is a Lotus Pharmaceuticals Company.

Mission statement:
Norwich Clinical Services is committed to maximizing customer satisfaction and strives to achieve the goal of excellence, through a continual improvement of our processes, systems and services, in delivering high quality projects meeting regulatory requirements in full compliance with GCP, GLP and all applicable good practices in a timely manner.

All levels of the organization are dedicated to the process of exceeding customer requirements

Oroxcell is an independent research organization (CRO) offering research services assessing the safety, toxicity and efficacy of active ingredients and finished formulations.

Specialized in in-vitro testing, particularly in 3D Human Models, Oroxcell is developing its business on two fronts:

• Safety & efficacy testing: From screening to GLP Compliant studies, we provide well established In-vitro platform, 2D and 3D models, for performing routine and regulatory safety testing, ADME (Absorption, Distribution, Metabolism, and Elimination) and Toxicity (sensitization, phototoxicity and genotoxicity) tests, bioanalytical studies, for evaluating pharmaceuticals, medical devices, cosmetics, nutraceuticals, home care and chemical products.

• Research & Innovation: Oroxcell provides a wide range of services including R&D project management and technical support, international consortium setup and management and regulatory & toxicology consulting.
We assist you in selecting or developing the best alternative testing methods for your safety and efficacy issues.

Oroxcell has been certified GLP compliant (Grade A, the highest grade) since 2011 by the French National Medicines and Cosmetics Safety Agency, ANSM.


Website: http://www.oroxcell.com
Contact: contact@oroxcell.com

PHARMA-STATS (PS) is a statistical consultancy service provider primarily focused on the formulation development, design, analysis and reporting of data from clinical trials and post-marketing surveillance with bioequivalence studies. As experts in statistical solution provider, PS provides high-quality teams that offer efficient outsourcing solutions for:

• Biostatistics
• R/SAS Programming
• Statistical Consultancy for Formulation Development
• End to End Solution for Regulatory Statistical Query Response
• Data Safety Monitoring Board (DSMB)
• Various stage of Biostatistical Training to Industry Professionals and fresh Post Graduates

PHARMA-STATS can offer study level support, small level functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe. PS has become the supplier of choice for many manufacturers and sponsors companies from top tier pharmaceutical giants through to the UK to India. Our number one priority is ensuring on-time, quality work. Every project undertaken is supervised on methodology and internal QC processes.

PS also support pharmaceuticals, CROs to reach out to permanent and contractual statistical and programming staff.

PHARMA-STATS is known as Single Point Statistical Solution Provider for Pharmaceuticals and Medical Devices.

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