About RegOps
RegOps is a global regulatory consulting firm partnering with pharmaceutical, medical device, and consumer health companies to navigate complex regulatory landscapes and accelerate market access worldwide.
We provide end-to-end regulatory services across the product lifecycle—from early-stage strategy and dossier preparation through submissions, approvals, and post-market compliance.
Our team brings over 50 years of combined experience across major regulatory frameworks, enabling clients to move confidently through the approval process in the USA, EMEA, APAC, and India.
RegOps By The Numbers
Pharmaceutical & Biotech
Regulatory strategy, IND/NDA/ANDA submissions, CTD dossier compilation, variations and lifecycle management, labeling, and pharmacovigilance support.
Medical Devices & Diagnostics
510(k) and PMA submissions, CE marking under EU MDR/IVDR, technical file preparation, clinical evaluation reports, and post-market surveillance.
Consumer Health & Cosmetics
Product notifications, safety assessments, claims substantiation, and compliance with regional regulations including FDA OTC monographs, EU Cosmetics Regulation, and CDSCO requirements.
50+
years of expertise and with a team of passionate and skilled global regulatory experts.
Our Approach
Regulatory pathways are rarely straightforward. Agencies differ in expectations, timelines shift, and a single documentation gap can delay launches by months. We work as an extension of your team—anticipating hurdles, streamlining submissions, and maintaining direct dialogue with authorities when needed.
Our clients range from emerging innovators bringing first-in-class therapies to market to established manufacturers expanding into new geographies. Regardless of scale, we apply the same rigor: meticulous preparation, clear communication, and accountability for outcomes.
Global Reach, Local Expertise
Regulatory success demands more than translation—it requires understanding how each agency interprets guidelines, what triggers queries, and where flexibility exists.
We maintain deep working knowledge of requirements across FDA, EMA, MHRA, TGA, Health Canada, PMDA, NMPA, CDSCO, and other national authorities, ensuring submissions are optimized for each market.