clinical research company in navi mumbai

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CLINICA provides expert services in all key Areas of the clinical operations

Solutions Offered

Clinica offers integrated solutions as per your requirements, together, we can do far better..

CLINICA Research Solutions LLP is a Navi Mumbai based full-service Clinical Research Organization (CRO) with a focus on human studies. Comprehensive services provided by us support pharmaceuticals (Allopathic, Herbal, and Homeopathy medicines), Nutraceuticals, Cosmeceuticals, Biotechnology, Medical Diagnostics and Medical Device companies with their pre and post-approval clinical development strategies.

Happy Clients

Projects completed, our services, clinica provides expert services in all key areas of the clinical operations, clinical operations, data management, biostatistics.

Quality Assurance

Medical writing, solutions we offer.

Phase II - Phase III Clinical Research

CLINICA offers Clinical Trial Services through an established clinical trial site network

Late Phase and RWE/RWD Capabilities

A highly qualified team leads our Late Phase Research and Real World Evidence (RWE) efforts

Medical Devices and Diagnostics Trial Capabilities

CLINICA specializes in medical device and diagnostic clinical development.

Biologics, Biosimilars and Pharmacokinetic Studies

The bioanalytical component of pharmacokinetics (PK) is the most critical aspect of a PK study

Herbal, Nutraceuticals, Homeopathy medicines Studies

CLINICA has expertise to perform studies with Herbal, Nutraceuticals

raptim research pvt. ltd.

Operating with the latest COVID-19 guidelines

Raptim Research Private Limited (formerly known as Raptim Research Limited), is a global independent and internationally accredited Contract Research Organization (CRO), established in 2005 with state-of-the-art clinical research facilities in Mumbai and Gandhinagar (India).

Our Services

• Healthy Subject (Bioequivalence & Bioavailability) Studies
• Patient Based Studies

In-Vitro Studies

• In-vitro Release Rate Test (IVRT) & In-vitro Permeability Test (IVPT)
• In-vitro binding Studies
• BCS Biowaiver Studies
• In-vitro Feeding Tube Studies

Special Studies

• In Vivo Tape Stripping
• In Vivo Dermal Microdialysis
• Skin Blanching studies
• Skin Irritation and sensitization test
• Glucose clamp Studies

Clinical Trials

• Early Phase Clinical Trials
• Phase II-IV Clinical Trial & Post marketing studies

We apply innovative tools and processes to our clinical development and support end-to-end services under the Clinical Research domain for all Global Pharmaceutical companies. With our experience and enhanced capabilities, we are in a unique position to assist our Sponsors with unparalleled support and provide them a single, global research network.

ASSAY LIBRARY

Your Trusted Partner in Bioanalytical Method Development and Validation

With a proven track record of excellence, Raptim Research Lab stands as a premier provider of bioanalytical method development and validation services. Having served leading pharmaceutical companies both in India and abroad, we take pride in our portfolio of over 500 validated methods.

Our expertise lies in delivering tailored solutions to meet the unique needs of our clients, ensuring accuracy, reliability, and regulatory compliance every step of the way. Whether it’s method development for new compounds or optimization of existing protocols, our team of experienced scientists is dedicated to delivering results that exceed expectations.

Partner with Raptim Research Lab and unlock the full potential of your pharmaceutical research endeavours.

At Raptim Research Pvt. Ltd., we are committed to ensuring patient safety while minimizing disruption and keeping studies on track during this evolving time.

Our sites in Navi Mumbai and Gandhinagar are following the protocols necessary to conduct studies with highest standards of care and safety:

• Social Distancing Protocols have been applied throughout our sites
• Volunteer Areas such as bedding facilities are kept at a distance
• Across the facilities, hand wash zones are marked, and sanitizers are available
• Training has been conducted on new anti Covid-19 measures implemented
• In association with clients and partners, modifications are being made to studies to reduce volunteer visits, avoid exposure to immunosuppressive drugs and monitoring safety of the patients at different time during the study
• Enhanced screening for all studies are being carried out
• Procured kits to conduct testing for Covid-19 at the diagnostic laboratory
• All subjects to be oriented for social distancing measures at the facility along with being given protective gear
• Minimum contact is practiced
• An isolation area is created to separate any subject with influenza like symptoms immediately

We are complying with the FDA guidance for conducting clinical trials.

read fda guidelines here

GENECHT RESEARCH PVT. LTD.

An Independent Contract Research Organization (CRO)

For all your Generic Product Development needs, located in Navi Mumbai, India.

GENECHT RESEARCH

Genecht Research Pvt. Ltd. is an emerging Contract Research Organization aiming to provide fierce support for BA/BE and clinical trial studies of pharmaceutical, biotechnology and cosmetic industries across the globe.

Genecht Research Pvt. Ltd. ensures that all the studies performed are in compliance with ICH-GCP, GLP, GDP and applicable regulatory guidelines. We have established our policies that follows work ethics and we believe in accelerating success adhering to our principles, organically.

Genecht Research Pvt. Ltd. aims to provide high level of technical competence and customer service without compromising on quality, with strict adherence to the timelines and maintaining confidentiality.

Benefits of Partnering with Us

• Use of electronic Case Record Form (eCRF) to facilitate online data entry
• Use of QR code on vacutainers and RIA vials to avoid possible errors due to sample mix-up/ interchange
• Ensure quality conduct of study by adhering to the study protocol and inhouse SOPs. Facilitate continuous monitoring during the study off site through CCTV access
• Provide a broad range of skills, offering a complete spectrum of services covering all the needed elements to make your clinical research work successful
• Perform studies with a variety of subjects, population including healthy male/female, postmenopausal women, geriatric, pediatric, hypogonadal male and smokers
• Clinical and bioanalytical units are under one roof and easily accessible to volunteers and sponsor's/monitor's

PROJECT MANAGEMENT DEPARTMENT

• Project managers delivering all projects through superb co-ordination and with continuous communication with sponsor. Genecht has a highly-competent project management team who manage complex projects with great fineness and accuracy.
• Oversee the entire project flow from the first client Interaction through to the final report
• Offer post-submission query resolution to support product approval from the Regulatory authorities
• Providing client-specific project managers, increasing the ease of communication
• Genecht offer project management services to the clients who wish to have a world-class, scientific project manager supporting their projects.

MEDICAL WRITING DEPARTMENT

Our medical writers:.

• Prepare the study protocols and reports in line with the sponsor’s requirements and applicable regulatory guidance
• Co-ordinates with the ethics committee for the necessary approvals
• Provides full compliance with applicable regulatory requirements

REGULATORY DEPARTMENT

Our regulatory team:.

• Recommend to the sponsor whether to apply for BE NOC/T-License on need bases
• Apply for BE NOC/T-License in order to have approval for execution of BABE/ Clinical trial studies
• Review and complete required documentation for the applications to local regulatory bodies to ensure appropriate study-related approvals are in place on time
• Track the progress of all relevant DCGI/CDSCO approvals in coordination with the project management team
• Work with the project management team keeping them updated about the authorizations to ensure that all the required DCGI/CDSCO approvals are in place
• Set meetings with DCGI officials for any query resolution

SCREENING DEPARTMENT

• Genecht has dedicated team at Mumbai location responsible for ensuring that the sufficient number of volunteers meet the requirements of each protocol.

Our Screening Department:

• Recruit from a voluneers database across India that includes healthy adult male /female, postmenopausal female, elderly male etc.
• Utilize Online Volunteers Information System (OVIS), a comprehensive database to avoid cross participation amongs CROs

QUALITY ASSURANCE

Our quality department oversees.

• Standard operating Procedures
• Regulatory Guidance
• Regulatory Query
• Sponsor Query
• Support Investigational site during Inspection
• Routine Review of SOPs
• Compliance of various Processes
• Quality Review System
• Investigational Site Audit
• In-process Audit
• Retrospective Audit
• System Audit

Our Services

Bioavailability/bioequivallence (ba/be) studies, clinical trials services.

Ensuring drug safety globally

We are an independent clinical research organization

Accutest was founded in 1998 and has been offering BA/BE services to pharmaceutical companies in India and worldwide.

The company has achieved the highest quality standards, evident in its record of over 100 successful regulatory audits.

At a glance

Our services.

BA/BE Studies

Healthy subjects and patients (PK studies) for generics and biosimilars, incl. FTF and 505 (b)(2)

Clinical Development Services

Phase II to IV studies for small/large molecules, PMS, Nutraceuticals, therapeutic equivalence, clinical end point

Characterization, Clinical comparability (PK / PD, studies), Immunogenicity studies for Biosimilar products

Our Capabilities

Regulatory History

100+ regulatory audits

BA/BE lab in Mumbai with 26 LC-MSMS machines

Three clinics with 354 beds in Mumbai, Ahmedabad & Vadodara

Validated Assays

Over a 1000 validated assays

Interested in our services:

"unlocking the future through scientific excellence", join accutest research laboratories india private limited team at cphi barcelona 2023 - october 24th and 26th 2023.

Dear Valued Partners and Industry Enthusiasts,

We are thrilled to invite you to join our team at CPhI Barcelona 2023, one of the most prestigious events in the pharmaceutical and healthcare industry.

 [email protected]

 +91 9819767612 +91 9869102673

USFDA Approved CRO for Clinical Research

We are ISO 9001:2015 Certified Company

Our integrity and expertise is based on our highly qualified, Knowledgeable and experienced staff.

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Our modern laboratory facilities as well as the comprehensive management and quality assurance systems substantiate our international approach.

FDA approved analytical testing unit with GLP facilities to perform some of the most sophisticated laboratory analysis

Welcome to Anazeal

AnaZeal Analyticals & Research Pvt. Ltd. takes a privilege in announcing that they are "USFDA approved CRO". Earlier its facilities were inspected by Dutch FDA and an EU approved Analytical/Microbiological lab has been developed.

We are FDA approved analytical testing unit with GLP facilities to perform some of the most sophisticated laboratory analysis for the pharmaceutical, bulk drugs, cosmetic and ayurvedic formulation industry at Unit I.

Our Unit II facility is a Clinical Research Unit is involved in Phase II-IV clinical trials. We are also approved by Drugs Controller General (India), for Bioequivalence/Bioavailability studies.

It has been promoted by technocrats having 25 years of Experience in Quality systems (UKMCA, South Africa, MCC, WHO GMP), analysis (Instrumental, Chemical, Microbiological, Biological), Bioequivalence/Bioavailability studies, clinical Trials (Phase II to Phase IV) and documentation required for various overseas regulatory submission.

AnaZeal is the first customer-centric CRO. Founded by dedicated experts and built on an unwavering commitment to operational excellence, we are able to strategically balance science, medicine, operations, and commercial intelligence to achieve successful drug development.

We take a never satisfied approach. Tackling every clinical research program as an opportunity to demonstrate a deep commitment to each client's unique needs. We have successfully managed over 60 clinical trials across all geographical locations in India. Our expertise lies in fostering the development of life-changing medicines by integrating clinical trial methodology, operational acumen, and efficient technology.

Our Services & Specialities

Our Goal is to become your 'Trusted Partner' in Research

We are committed to achieve customer satisfaction by maintaining quality assurance and prompt service at all time.

We always maintain an effective quality management system through an active involvement of our key people.

We comply with all the statutory testing regulations to ensure the earliest release of the product.

We conduct appropriate training programs for all our people on a regular basis to achieve continuous improvement in accordance to our objective.

Our mission is to foster the development of life-changing medicines by integrating clinical trial methodology, operational acumen, and efficient technology.

Certifications

• LATIN AMERICA
• ME & Africa
• RUSSIA & CIS

CUTTING EDGE INNOVATION TO FIND A BETTER TOMORROW

R&d centres.

Our research team across our R&D centres comprises of several highly qualified scientists with expertise in formulation and analytical development and discovery of NCEs.

Sinnar The formulation R&D centre based at Sinnar, Maharashtra, India is Glenmark’s first R&D centre in India and is spread over 30,000 sq. ft. It is focused on Formulations Development & Analytical Research of Specialty and Branded Formulations for Global markets across dosage forms for therapeutic areas like Respiratory, Dermatology, Oncology, Cardiovascular, Anti-diabetes etc. It facilitates the research of Aerosols of various indications (MDIs, DPIs, Nebulizers and Nasal sprays) through some of the best experimental apparatus in the country.

Taloja Spread over 1,07,000 sq. ft. the R&D Centre in Taloja, on the outskirts of Mumbai, India is focused on identifying filing opportunities by doing effective product selection and patent landscaping with a vertical integration of API. The R&D unit works in co-ordination with the Intellectual Property Management team to develop cost effective and patent driven Generic Formulations. The centre is equipped for research on a variety of dosage forms such as oral solid dosages, semi-solids, parenteral (Complex Injectable & Liposomal Products) and aerosols for various indications.

Mahape Spread over 1,27,000 sq. ft, the R&D Centre at Mahape on the outskirts of Mumbai, India has end-to-end capabilities for discovery and development of New Chemical Entities (NCEs) from target selection to clinical development. The research facility is equipped with modern infrastructure required to carry out research activities like process & analytical chemistry, bulk actives, discovery, invitro and invivo, tissue culture, toxicology, antibody, pharmacokinetics supported by project management, clinical, regulatory affairs and IPM.

Biomedical waste annual returns Taloja Turbhe

Manufacturing niche products for a healthier world

QUALITY AT GLENMARK

Committed to consistently meet the highest regulatory standards

MANUFACTURING FACILITIES

State-of-the-art facilities delivering high quality products globally

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Contract Research Organizations in Mumbai

• Contract Research Organizations
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Mumbai is the most preferred place for most of the CROs (Contract Research Organizations) for Clinical Development and clinical research. There are many privately-owned well established CRO (Contract Research Organization) set up their offices and branches in Mumbai, the commercial capital of India.  Most of the clinical research organisation operates in Mumbai are multinational companies with a global footprint of operations (United States, UK and APAC).

The Contract Research Organizations in Mumbai mainly focus on clinical trial management and clinical monitoring, quality assurance, pharmacovigilance, regulatory submissions, clinical data management and biostatistics and medical writing. These CROs have clients ranged from big biopharma to the emerging biotechnology companies. Although the other cities like Hyderabad, Bangalore, Chennai and New Delhi is making quick progresses, Mumbai still remains the India’s Contract Research Organizations (CRO) capital.

Below are the list of Contract Research Organizations (CROs) in Mumbai. Please note some pharma companies have their own CROs and some diagnostics labs also involved in clinical trial process. We have included those company information also in the below list.

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Medpace Locations India

Thane-Belapur Road, Unit No. 1203, 12th floor, Building Q2 Navi Mumbai, India 400701 Tel: 91-22-412-83900

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We’re committed to providing resources and benefits that empower our people to live, work and play with purpose every day. It’s all part of our high-performance culture, and our mission to make a difference.

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[Freshers] Teva Hiring Clinical Research Scientist

Location: Navi Mumbai, India, 400706

Who We Are: At Teva Pharmaceuticals, we are united by a common mission: to make good health more affordable and accessible, enriching the lives of millions worldwide. With a presence in nearly 60 countries and a diverse workforce representing various nationalities and backgrounds, we are proud to be the leading manufacturer of generic medicines. Our products, many of which are listed on the World Health Organization’s Essential Medicines List, are taken by at least 200 million people every day. But our quest for innovation and impact continues, and we are always seeking new ways to make a difference with the help of passionate individuals like you.

Job Description: As a Clinical Research Scientist I at Teva Pharmaceuticals, you will play a crucial role in ensuring the proper conduct of clinical studies, contributing to our mission of advancing global healthcare. From ensuring compliance with regulations to overseeing study protocols and documentation, you will be instrumental in driving forward our commitment to excellence in clinical research.

Responsibilities:

• Ensure compliance with all applicable regulations and complete required forms before study initiation.
• Familiarize yourself with the GCP, EC/Sponsor agreed protocol, and Lotus SOPs, adhering to ethical principles outlined in the declaration Of Helsinki.
• Review and provide timely input on study protocols, CRFs, ICDs, and other relevant documents.
• Obtain ethics committee approval and address any inquiries or concerns raised by the EC.
• Conduct or supervise all clinical or medical aspects of the study personally.
• Train study personnel on protocol, study plan, and trial-related duties.
• Generate necessary trial-related documents in compliance with the protocol.

Requirements:

• 0-2 years of experience in Clinical Investigator BABE Studies.
• Female candidates preferred.
• MBBS degree.

How You’ll Spend Your Day: Your day will be filled with meaningful tasks that contribute directly to the success of our clinical research endeavors. From ensuring protocol compliance to conducting or supervising study procedures, you will be at the forefront of advancing healthcare solutions that positively impact lives around the world.

Application Link

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