We are pleased to announce that Statandocs has become a Partner of the Business Program at the 27th International Exhibition of Equipment, Raw Materials, and Technologies for Pharmaceutical Production Pharmtech & Ingredients.

Founded in 2016 by experts in clinical and preclinical research, Statandocs was established with the goal of supporting the pharmaceutical industry in preparing high-quality clinical and registration dossiers.

The company’s specialists provide consultations on drug development strategies, medical writing services (from concept notes and protocols to key clinical trial documents), statistical support, and the preparation of CTD dossiers in accordance with Russian and Eurasian Economic Union (EAEU) legislation.
 

Areas of Activity

Statandocs’ growth has evolved alongside the pharmaceutical industry. With the introduction of the EAEU Good Pharmacovigilance Practice Rules in 2017, the company was among the first to offer services for preparing key documents such as pharmacovigilance system master files (PSMFs). These documents are now developed by certified specialists and are widely accepted by regulators without comment.

A strong focus is placed on information security. The company’s IT and data management teams ensure the implementation and operation of electronic CRF and IWRS services, as well as the development and validation of databases containing data from tens of thousands of patients. Statandocs was also one of the first to introduce electronic OTD (eOTD) services, successfully validated and adopted by regulators in Russia and Kazakhstan.

In 2019, Statandocs launched a service for writing SmPCs, package inserts, and conducting user testing, including remote testing during the pandemic period.

Since 2023, Statandocs has been a member of the Lomonosov Educational Cluster of the Vorobyovy Gory Innovative Scientific and Technological Center of Moscow State University.
 

In-House Software

• EAEU ETD (Statandocs Chronicle) - for organising and managing the life cycle of medicines and medical devices.
• Pharmacovigilance – automated monitoring of literature sources.
• RWD and Clinical Trials (xClinica) - eCRF and IWRS platforms.

Experience and Achievements

Since 2016, Statandocs has implemented over 4,500 projects across all stages of the product life cycle — including medicines, medical devices, dietary supplements, and cosmetics from concept development to registration and post-marketing activities.

The company has worked with more than 220 clients in Russia and the CIS, including global leaders such as Pfizer, AstraZeneca, Merck, GSK/Haleon, Pierre Fabre, Bayer, Takeda, Stada, Gilead, Berlin-Chemie, MSD/Organon, Pohl Boskamp, Dr. Reddy’s, as well as leading local companies including R-Pharm, Microgen, Akrikhin, Geropharm, Binnopharm Group, Valenta Pharm, Santo, and Minskintercaps.

Key Results

• Over 3,000 research documents (RWD and clinical) submitted to regulators in Armenia, Belarus, Vietnam, Georgia, the EU, Kazakhstan, Moldova, Russia, the USA, Tajikistan, Uzbekistan, and Ukraine.
• More than 300 electronic IRCs, covering 800+ centres and 80,000+ participants.
• Over 500 clinical trial and RWD reports successfully submitted in Belarus, the EU, Kazakhstan, Russia, the USA, and Ukraine.
• More than 1,000 expert opinions and consultations issued to support preclinical and clinical development, including six programmes from first-in-human studies to registration of original molecules.
• Over 6,000 CTD sections developed in the EAEU format.
• More than 3,000 dossier sequences in eOTD (EAEU XML) format successfully submitted in Russia, Belarus, Kazakhstan, and Armenia.
• Over 500 user tests conducted for EAEU package inserts.
  
   

In 2024, Statandocs contributed to the creation of over 45% of all dossiers submitted in the EAEU.

The company has also completed more than 100 audits and inspection preparations for compliance with Good Practices (GxP).

Statandocs is a regular participant in the Eurasian Economic Commission’s working group on medicines and is a developer of regulatory legal acts in the field of real-world clinical practice.

Get a free ticket with promo code “pharmtech” and visit the Statandocs booth at Pharmtech & Ingredients 2025.