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More than 20 years of experience managing integrated drug development programs
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NMPA GLP-certified facility
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Successfully filed more than 120 IND/CTAs in the last 2 years on behalf of our partners
If you need an insightful partner with a local presence in India, you will benefit from our experience and cross-functional expertise. Since 2007, we’ve worked in India to meet unique clinical trial requirements and provide access to comprehensive drug development solutions. As your collaborator, we can help transform your results.
Solutions in India
We leverage our experience to share unique perspectives and proactively anticipate your needs. Our neighboring operational units offer several solutions to meet your specific requirements:
Nonclinical Development: Our dedicated NMPA GLP certified facility in Shanghai, China features a number of accreditations to fulfill global quality standards (FDA, OECD, etc.). Teaming up with global resources and partners in China, we offer solutions for a full range of safety assessments needed by IND filing and FIH. Specific solutions for small molecules and biologics include:
- Lead Optimization
- Safety Assessment
- Bioanalysis
- Drug Metabolism and Pharmacokinetics
- Chemistry, Manufacturing and Controls
Clinical Testing - Central Laboratory Services: Trust in the experience of the Singapore central lab to deliver consistent, quality data and on-time data transfers for faster submissions. Operating since 2000, we offer one of the biggest central laboratories in the world, serving 16 countries in the Asia Pacific region.
- Core Laboratory Testing services:
- Genomics Services
- Special Chemistry
- Immunochemistry
- Hematology
- Flow Cytometry
- Specimen Management and Biorepository
- Safety Testing
- Anatomic Pathology
- Biomarker Services
- Scientific Consultation
- Data Management
- Project Management
- Investigator Site Support
- Global Logistics
Local Expertise
We have created strong relationships with many prominent medical centres throughout the country to deliver additional efficiencies in your process. Our network of local scientific experts also offers additional benefits for your project, including:
Regulatory support: Get experienced consulting with your product development plan and regulatory submissions from our regulatory personnel who proactively stay abreast of the latest regulatory changes.
India has been attractive market for drug development activities for the following reasons:
- Lower cost: The cost of conducting clinical trials within the India is typically lower than Western countries.
- Large population: With over 1 billion people, India offers many treatment-naïve patients with a rising incidence of so-called Western, chronic-lifestyle diseases.
- Emerging Market: The need for registration of new medicines in India has never been greater. The regulatory challenges of product registration in India are vast, including the need for local patients to be enrolled in clinical trials.
Locations
With our unique combination of regional knowledge and global experience, we’re ready to work together and explore what’s possible. Learn more about how we can deliver your results.
Sales/General Enquiries:
+91 22 6822 1500
Fax:
+91 22 6822 1501
Office Address:
Building No. 1 ,UNIT No: 601, Raheja Mindspace,
Plot Nos : Gen/2/1/D, Gen 2/1/E, Gen/2/1/F AT MIDC,
Trans Thane Creek Industrial Area, Shiravane,
Navi Mumbai – 400706 , Maharashtra , India