a secure online regulatory software toolset at your fingertips for a modest monthly subscription

Whether you’re an independent regulatory affairs consultant or a regulatory professional employed full time by a pharmaceutical company, you can benefit from a secure application to manage your product and licence information throughout the life-cycle process

with full eCTD creation and viewing capabilities...

Samarind RMS is a fit-for-purpose regulatory submissions software application that has been designed from the outset as a user-friendly and time-efficient toolset for pharmaceutical industry professionals who deal with regulatory affairs.

Samarind RMS is a fit-for-purpose time efficient toolset, which allows you to create and submit your electronic dossiers in the correct eCTD format

The latest driver is the fully electronic Common Technical Document (eCTD) as defined by
the International Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH) and the various regional authorities

pharmaceutical regulatory management

In today's pharmaceutical industry there are ever increasing demands on regulatory affairs and pharmacovigilance departments; no more so than when managing the submission and maintenance of product licence information to the relevant authorities.

At Samarind we thoroughly understand these demands and the stringent procedures that can give regulatory professionals a constant headache, such as the enigma of eCTD!

Working closely with experienced pharmaceutical industry professionals, we have developed Samarind RMS, a robust user-friendly software application which precisely manages the key areas of product licence acquisition and maintenance, including eCTD.

Key benefits of Samarind RMS

reduces the costs of managing your licences
improves accuracy of regulatory data
provides fast and accurate reporting
provides greater flexibility of working
improves overall efficiency of regulatory data management

Samarind announces further expansion

Samarind announces further expansion with the appointment of Dr. Olaf Schoepke as its Director of Strategic Development.

FREE Webinar 'Building a link between eCTD and XEVMPD'

Samarind is pleased to announce the second event in its joint webinar series with Qdossier. The main presentation will be delivered by Michiel Stam, Manager of Regulatory Operations at Qdossier, followed by a Q&A session with our expert panel.

Samarind Ltd achieves ISO 9001:2008 certification!

Samarind has achieved ISO 9001:2008 certification for its quality management system, covering the full scope of the company's activities - computer network and software design, development, implementation and support.

Work with us

Our Windows software, first developed in 2004 and now in its fourth major version, has just been joined by our revolutionary 'On Demand' version, which is entirely web-based.

Worked with us

With a large portfolio of products and a complex supply chain mechanism to support it, we needed a dynamic and flexible software system to cope with all of the variables. We are very impressed with Samarind's openness to our needs and in particular, their willingness to work in partnership with Fresenius-Kabi, to ensure our needs are met precisely.

Dr. Dr. Michel Mikhail
Chief Regulatory Officer & Executive Vice President
Global Regulatory Affairs, Fresenius Kabi