Regulatory Services And
Global Compliance
We empower pharmaceutical, biotech, medical device, and nutraceutical companies to achieve faster approvals, regulatory clarity, and long-term compliance across diverse markets.
One Partner Across All Product Categories
Our teams combine scientific depth, regulatory intelligence, and real-world agency experience to ensure your product meets both current expectations and future scrutiny.
Pharmaceutical products
Biologicals and Biosimilars
Invitro diagnostics under evolving global frameworks
Nutraceuticals and food supplements
Medical devices across all classes, including software and combination productsOur Services At A Glance
Your trusted partner for regulatory excellence and clinical success
Dossier preparation and submission (IND, NDA, ANDA, DMF, MAAs)
Structuring, authoring, and compiling CTD/eCTD dossiers for IND, NDA, ANDA, DMF, and MAAs in line with FDA, EMA, MHRA, and CDSCO formats. Covers end-to-end lifecycle: gap-checking source data, module authoring, technical validation, and electronic submission support.Product registration and approval facilitation for Drugs and biologicals
Coordination of complete registration workflows for small molecules and biologics, from pre-filing meetings to post-approval variations. Support includes query management, deficiency response strategy, and alignment of CMC/clinical data with country-specific requirements.Regulatory consulting and strategic planning for market entry in India, US, UK, and Europe
End-to-end regulatory pathway design for new and existing products targeting India, US, UK, and EU markets, aligned with current regulatory requirements. Includes risk assessment, route selection (e.g., centralized, national, 505b (1)/(2), ANDA), and a phased roadmap to minimize approval timelines and avoid costly rework.Gap analysis, regulatory intelligence, and agency liaison (USFDA, EMA, MHRA, CDSCO, etc.)
Systematic review of existing documentation against current guidelines and regional expectations to identify gaps and risks. Direct liaison support for scientific advice meetings, pre-IND discussions, and day-to-day communication with agencies like USFDA, EMA, MHRA, and CDSCO.Gap assessment of existing data vs. CDSCO, FDA, MHRA, EMA expectations.
Technical assessment of CMC, nonclinical, clinical, and PV data against specific expectations of CDSCO, FDA, MHRA, and EMA.Labelling, promotional material review, and expert regulatory dossier writing.
End-to-end regulatory review of prescribing information, carton/label artworks, IFUs, and patient information aligned with local labelling rules.Why Companies Across The Globe Work with Us
True Global Mindset
We combine region-specific expertise with a globally harmonized regulatory approach.
Deep Scientific & Regulatory Know-How
Our team includes former regulators, experienced dossier authors, and global submission specialists.
Faster Time-to-Market
Our proactive strategies reduce surprises, rework, and approval delays.