Full range of
Services
We offer a full range of services organized into 5 expertise units:
Regulatory Affairs, Clinical, Pharmacovigilance, Quality & ePharma Solutions (ePS).
We provide comprehensive and interdisciplinary consultancy support to assist you secure a sustainable future for
your business. We cut through complexity and creates clarity to ensure compliance.
For our clients, eKemia delivers cost-effective and tailored solutions with the highest quality standards. Whether your need a short-term project assistance, ongoing services or a long-term engagement, we will design and adapt our solutions specifically to your organization.
We operates in 2 complementary ways:
Outsource your need, we will set a fully dedicated eKemia staff to
act as an extension of your own team, with a high level of
flexibility and cost-effectiveness.
Request an Insource support and, we will assign a dedicated experts to operate
on-site and support you on your ongoing projects.
Expertise
Units
Expertise Units Details
through the maze of regulations, eKemia supports you streamline the regulatory processes for your products. From the registration to the post-approval maintenance, we offer our support on:
-
Regulatory Strategy Mapping
Registration & Life Cycle management (LCM)
Clinical Trials Application management
Regulatory Writing
Regulatory Intelligence
Market Access Support
To tackle the compliance challenges, eKemia will provides expertise and support on every step of your the Clinical Trials:
-
Start-up Management
Monitoring & Site Management
Biostatistics & Data Management
TMF & eTMF Management
Medical Writing
Onsite support
For your PV compliance, eKemia provides a set of services to support you team:
-
PV Writing (PSUR, RMP, PSMF…)
Safety LCM
Safety Signal Detection & management
24/7 Safety Hotline (Contact-us for details)
Whether you need to set a new Quality System or to update the actual one which became innefective over time, eKemia offers to your organization an exhaustive Quality Management services, which include:
-
Quality system (QS) audit
Quality system (QS) development (Quality Manual, SOP...)
Quality Risk Management
Document Management
At eKemia we have set the "zero-paper" policy as objective, and we believe that switching to a full electronic work management is vital for our industry. We can help your organization reach this objective through a set of electronic management tools.
Furthemore, 2019 will be a critical year for your regulatory department, with the eCTD regulation. We have the dedicated processes to anticipate these challenges and avoid any regulatory deadlock.
-
Paper & Nees formats to eCTD conversion
eCTD, ePSUR, Baseline creation and update
Mapping and transition from xEVMPD to ISO IDMP
Projects & Admin Tasks automation
Computer System Validation
If you've got any questions or queries about our services, please get in touch. We will find the right way to help you.