Bio-Pharma & MedTech Services
GMP and Regulatory Consultancy services specifically tailored for the Bio-Pharma and MedTech industries. We understand interdepartmental dynamics more deeply than standard consulting practices.
Our Service Offerings
Specialized consultancy services for Biologics, Medical Devices, In-Vitro Diagnostics (IVDs), and Software as a Medical Device (SaMD)
Startup Support
Comprehensive support services to help bio-pharma and medtech startups navigate quality, regulatory, and funding challenges.
- Staff Augmentation for Quality & Regulatory
- QMS Audit assistance and Bench testing
- Manufacturing facility design
- Grant application assistance (BIRAC, PRIP, ELEVATE)
- Investor connections
Prototyping & Technology
Advanced technology development and compliance testing for innovative medical devices and diagnostics solutions.
- Wearable & IoMT development
- Point of Care diagnostics
- Remote patient monitoring
- EMI/EMC compliance testing
- Cybersecurity testing
Quality & Clinical Consulting
Expert guidance on quality management systems, certifications, and clinical study execution for regulatory compliance.
- ISO Certifications (13485, 27001, 9001, 15189, 17025)
- MDSAP, QMSR, NABH, NABL accreditations
- Clinical protocol development
- IEC approval and CTRI registration
- Health Technology Assessment
Regulatory, Licenses & Registrations
Global regulatory strategy and approval support for medical devices, biologics, and in-vitro diagnostics across major markets.
- India: CDSCO Licenses (Manufacturing, Import, Test)
- USA: USFDA (510k, IDE, Denovo)
- Europe: CE Certification (EU MDR & IVDR)
- Predicate analysis & Gap assessment
- Technical Documentation (DMF, PMF, CER)
FAST-TRACK YOUR INNOVATION IN
BIOLOGICS, MEDICAL DEVICES, DIAGNOSTICS & DIGITAL HEALTH
Expertise Across Global Compliance Frameworks
Ready to Accelerate Your Product Journey?
Partner with us across the entire product development and commercialization lifecycle—from prototype to market entry and beyond.