Samahitha Research Solutions is a Bengaluru-based Contract Research Organization (CRO) specializing in comprehensive clinical research, regulatory consulting, and training services for the pharmaceutical, biotechnology, and medical device industries. With a commitment to scientific excellence and regulatory integrity, Samahitha enables life sciences companies to bring new therapies to market efficiently and compliantly.
Brief History
Founded by Sri Vatsa GS, Samahitha Research Solutions was established with a vision to deliver end-to-end research and regulatory services in alignment with global clinical development needs. With its headquarters in the biotech hub of Bengaluru, India, Samahitha has emerged as a trusted CRO offering specialized services across the clinical research lifecycle.
Core Business
Samahitha’s core operations revolve around supporting biopharma, academic institutions, and healthcare organizations in their research and development endeavors. The company provides full-service and functional service outsourcing (FSO) models covering:
- Clinical trials
- Regulatory affairs
- Drug development consulting
- Training and skill development
Product and Service Offerings
Samahitha offers a robust portfolio of services:
-
Clinical Research Services
- Medical Writing & Scientific Documentation
- Pre-clinical Study Coordination
- Clinical Trial Operations (Phase I–IV)
- Clinical Supply Management
- Clinical Data Management
- Biostatistics & Data Analytics
- Pharmacovigilance & Drug Safety Monitoring
- Site Management and Feasibility Studies
-
Consulting Solutions
- Regulatory Strategy and Submissions (IND, ANDA, NDA, 510(k))
- Drug and Biologic Product Development Consulting
- Medical Device Design, Documentation, and Submission Support
-
Training Services
- Certification Programs in Clinical Research and GCP
- Workshops and Corporate Training for Research Professionals
- Curriculum development for life sciences institutions
These offerings are designed to meet the diverse needs of sponsors, investigators, and emerging biotech ventures.
Specialisation and Core USP
Samahitha’s unique strengths lie in:
- Integrated CRO Capabilities: End-to-end coverage from discovery to regulatory filing
- Experienced Talent Pool: Cross-functional teams with domain expertise in pharmacology, regulatory science, and data analytics
- Regulatory Insight: Proficient in global regulations including US FDA, EMA, CDSCO, MHRA, and TGA
- Customizable Engagement Models: FSP, full-service, and hybrid delivery frameworks
Financials
Though privately held and not publicly disclosing revenue figures, Samahitha is categorized as a mid-size CRO with:
- Over 30 active projects annually
- Client retention rate exceeding 85%
- Serving 20+ sponsors and collaborators across India, US, and APAC
- Estimated operating revenue in the range of ₹5–10 crore (~$600K–$1.2M USD)
Shipment Data
As a service provider in the life sciences sector, Samahitha does not deal in physical goods. However, it enables regulatory and data documentation submission for:
- US FDA Investigational New Drug Applications (IND)
- European Medicines Agency (EMA) submissions
- CDSCO compliance for India-based trials
Target Market
Samahitha’s primary clientele includes:
- Pharmaceutical and Biotechnology Companies
- Medical Device Developers
- Academic Research Institutes
- Hospitals and CROs needing FSP partnerships
Capabilities
- Clinical Trial Site Network across Tier I and Tier II Indian cities
- In-house Data Management and SAS Programming Team
- Regulatory Document Review and eCTD Publishing
- Customizable Training Modules and Certification Platforms
Certifications and Compliance
- Follows ICH-GCP, CDSCO, and ISO 14155 (for medical device trials)
- Trained personnel for pharmacovigilance per EU and US FDA regulations
- Maintains compliance with Data Protection and Patient Confidentiality protocols
Customer Testimonials
"Samahitha’s expertise in regulatory submission and their ability to guide our drug development process saved us months of time and cost."
— VP, Regulatory Affairs, Indian Biotech Firm
"Their clinical data management team worked seamlessly with ours and produced top-quality deliverables. We look forward to a long-term partnership."
— Clinical Operations Head, US-based Sponsor
Major Achievements
- Delivered successful regulatory submissions for 20+ drug and device applications
- Trained over 1,000 professionals and students in clinical research methodologies
- Recognized by Indian CRO Association for adherence to international best practices
- Provided site management for multi-centric trials across oncology, neurology, and infectious diseases
