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Reg360: Life Sciences Consulting

We've developed regulatory compliance for several products across numerous therapeutic areas

From dietary supplements, innovative device-drug-drug-device products, biologics and diagnostic software to radio-imaging scanners , our regulatory experience spans several therapeutic areas. We have helped a handful of successful clients develop technical files and audit readiness, helping them navigate the maze of changing regulations in manners that assure consistent product safety to their patients.

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REGULATORY PROJECTS

Our Top Rated
Regulatory Projects

Submissions to different territories

Critical to compliant submissions are health authority meetings which we have harnessed to bridge the gap between product science and regulatory expectations. Here are some territories we have excelled in.

Major Markets: North America & Europe

FDA (US), Health Canada, EMA (Europe), MHRA (UK)

Emerging Markets: ASEAN, LATAM, Asia

HSA (Singapore), ANMAT, MFDS (Korea), NMPA (China), PMDA

Rest of the World: Oceania, Africa, ME

TGA (Australia), NAFDAC (Nigeria), JFDA (Jordan), EDA (Egypt)

THERAPEUTIC AREAS

Our Specialized Therapeutic Areas

Growing Specialties

While we try hard not to be too niche, we bring domain expertise from several specialties in medicine courtesy of our growing team of experts who are also constantly evolving.

Rare & Serious Diseases with unmet needs

Diseases with small patient populations often lead the way in breakthrough discoveries and First-in-Human therapies.

Common Diseases & Pathologies

Common diseases broaden existing knowledge on well-understood diseases, providing potential for enhanced therapies.

Software Products & Public Safety

Emerging technologies aimed at deep learning of patient conditions potentially increase diagnostic accuracy and improve clinical decision-making.