Clinmark

Regulatory

Clinical Trials

CA/EC Approvals

Regulatory submissions are the most critical milestones in the clinical study. National regulations influence the submission and timelines. There are significant differences between countries and sometimes even within countries between local Ethics Committees, in the way they work and what they require. Prior to study initiation, Clinmark ensures that all required essential documents are collected, reviewed, and approved per regulatory requirements. Clinmark’s dedicated team provides a comprehensive range of submission and approval-related services for the customers. We can assist in efficient communication, including:

Compiling submission packages
Competent Authority submission
Ethics Committee submission
Local hospital board approvals
Contracting
Other relevant permission
Study amendments and study termination

eSubmission (eCTD/CDISC)

IMP Manufacturing

Clinmark is not only a CRO but also a specialized full-service provider. We offer flexible solutions to meet all your individual requirements. Our range of services includes:

Importing and exporting of IMPs
Labeling and packaging of products in the GMP zone
QP release and QP declaration
Controlled environment warehousing and transportation according to GDP

Regulatory

In order to bring a product to the market, pharma or biotech company will require a partner ready to provide you with a Product Development.

Clinmark Consulting Department supports clients on very early stage of product development by providing an optimal regulatory path and creating Product Development Plans that gives a practical knowledge, which trials should be performed for the specific product or Clinmark’s experts provide such expert advice in all areas of Product Development, starting from preclinical strategies, regulatory advice, study design and protocol preparation through other parts of a product development process.

The above-mentioned Plan includes the following products:

medicinal products
veterinary medicinal products
medical devices
cosmetic products
food supplements

Dossier Preparation

Clinmark’s team has extensive expertise regarding Regulatory Affairs and is always ready to support Clients in all regulatory aspects. Our Experts assist in dossier preparation and submission process of the following products:

medicinal products – Common Technical Document (CTD, eCTD)
veterinary medicinal products – Common Technical Document (CTD, eCTD)
medical devices – Technical Documentation (TD)
cosmetic products – Product Information File (PIF)
food supplements – Food Supplement Documentation

Product Registration

Clinmark’s team evaluates existing documentation in order to manage marketing authorization process through one of these procedures available in the EU.

Clinmark can provide advice from dossier preparation and submission through marketing authorization support (also for companies from non-EU countries). Clinmark’s consultants can guide the Clients through the whole regulatory process and provide one with full-service solutions at any stage of product development.