Independent Regulatory and Technical Writing Consultancy

Your Partner in Navigating the Regulatory Pathway

ARKA RegWriting Consulting is an independent consultancy specialising in regulatory and technical writing for medical device regulatory submissions.

We support medical device manufacturers, CROs, and MROs by preparing high-quality regulatory documentation across a broad spectrum of device classifications, from Class I to Class III. Our expertise helps ensure your submissions are clear, compliant, and aligned with global regulatory expectations.

Regulatory & Technical Writing Made Easy With ARKA

Just like navigating a complex maze, regulatory submissions can feel overwhelming multiple pathways, strict requirements, and countless documents to manage.

With ARKA, regulatory and technical writing becomes structured, clear, and stress-free. We simplify the process from SOPs to technical files, Clinical Evaluations to submissions ensuring every step leads to compliance.