Tag: Regulatory
Pulse raises $4 million to build full-stack medical equipment manufacturing brand
The company will use the funds to set up an R&D hub, accelerate product development, secure regulatory certifications, and build distribution across India
Pfizer INDovation awards grants of over ₹8 Crore to 14 Indian...
In partnership with DPIIT, Department of Pharmaceuticals and NITI Aayog, the INDovation program provides MedTech startups with clinical and regulatory support, or deployment support in select Ayushman Arogya Mandirs in Maharashtra
ErlySign granted US FDA breakthrough device designation for its saliva-based oral...
The designation marks a significant global regulatory milestone for the company and underscores the potential of its technology to advance early cancer detection across international markets
Bharat Biotech’s Nucelion collaborates with Pandorum Technologies to advance exosome-driven tissue...
By leveraging Nucelion Therapeutics’ manufacturing capabilities, the partnership supports regional supply and regulatory readiness, marking a strategic step forward
Pharma industry leaders spotlight quality, sustainability & market diversification as export...
Indian Pharmacopoeia reinforced as a critical pillar of international credibility, reflecting India’s scientific rigour and regulatory maturity
India–Ethiopia advance pharma collaboration in high-level DCGI meeting
Ethiopian Health Ministry delegation explores regulatory alignment, Indian Pharmacopeia adoption, and expanded partnership opportunities with India’s drug regulatory ecosystem
Lupin Bioresearch Center receives zero observations from US-FDA
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
MTaI welcomes CDSCO’s draft guidance on medical device software
The association commended CDSCO for its proactive step in framing a comprehensive regulatory framework for Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)
India to host WHO – IRCH workshop on herbal medicine safety...
Three-day technical meet to feature hands-on training, case studies, and global regulatory dialogues
DBT backs 3D tissue models to replace animal testing amid evolving...
While the Department of Biotechnology supports cutting-edge non-animal methods for drug discovery and disease modelling, key gaps remain in validation protocols, regulatory engagement, and national data repositories.