Organization and management of preclinical studies of medicinal products in accordance with the requirements of the EAEU and the Russian Federation for subsequent registration.

We provide:
✔ Development of a preclinical study program
✔ Selection of accredited research laboratories
✔ Organization of toxicological studies
✔ Organization of pharmacological studies
✔ Analysis of study results
✔ Preparation of final reports
✔ Scientific and regulatory support throughout the project

Generic Medicinal Products
For generic medicinal products, the required scope of preclinical studies is determined based on the composition, manufacturing process, and characteristics of the active pharmaceutical ingredient.

Possible studies include:

• Acute toxicity;
• Subacute toxicity;
• Local irritation potential;
• Other studies required by regulatory authorities.

Innovative (Original) Medicinal Products
For innovative medicinal products, a full range of preclinical studies is conducted to assess safety and efficacy.

Possible studies include:

• Acute and chronic toxicity;
• Reproductive toxicity;
• Mutagenicity;
• Carcinogenicity;
• Immunotoxicity;
• Allergenicity;
• Safety pharmacology;
• Pharmacokinetics;
• Specific pharmacological activity.

Upon project completion, the client receives:

• A complete package of study reports;
• Expert evaluation of the obtained data;
• Documentation for the preparation of the registration dossier;
• Recommendations for progression to clinical studies.

Our advantages:

✔ More than 350 completed projects
✔ More than 13 years of experience
✔ Proprietary clinical center with 42 inpatient beds
✔ In-house volunteer database
✔ Certified ISO 9001:2015 Quality Management System
✔ Experience working in Russia and EAEU member states

Request a commercial proposal for registration services

We will assess the scope of work and prepare a commercial proposal within 1–3 business days.

We organize and conduct Phase I–IV clinical trials of medicinal products in compliance with GCP, EAEU, and Russian Federation regulatory requirements. We provide comprehensive project support throughout the entire study lifecycle, from protocol development to preparation of the final clinical study report.

What Is Included?
✔ Development of a clinical strategy for subsequent registration
✔ Preparation of the clinical trial protocol
✔ Preparation of documentation for regulatory authorities
✔ Selection of investigational sites
✔ Patient or volunteer recruitment
✔ Clinical trial monitoring
✔ Clinical data management
✔ Biostatistical analysis
✔ Preparation of the final clinical study report

Phase I clinical trials

• Safety and tolerability studies
• Pharmacokinetic (PK) studies
• Pharmacodynamic (PD) studies
• Drug–drug interaction studies
• Studies involving healthy volunteers

Phase II clinical trials

• Therapeutic dose selection
• Proof-of-concept studies
• Dose–response studies
• Development of the Phase III study design

Phase III clinical trials

• Confirmation of efficacy and safety
• Multicenter clinical trials
• Preparation of documentation and reports for marketing authorization

Phase IV clinical trials

• Post-marketing studies
• Real-world evidence (RWE) studies
• Observational programs
• Epidemiological studies
• Long-term safety assessment

Upon project completion, the client receives:

• A complete package of clinical study documentation;
• Validated clinical trial data;
• A statistical analysis report;
• A final clinical study report;
• Documentation required for marketing authorization of the medicinal product.

Our advantages:

✔ More than 350 completed projects
✔ More than 13 years of experience
✔ Proprietary clinical center with 42 inpatient beds
✔ In-house volunteer database
✔ Certified ISO 9001:2015 Quality Management System
✔ Experience working in Russia and EAEU member states

Request a commercial proposal for registration services

We will assess the scope of work and prepare a commercial proposal within 1–3 business days.

We organize and manage bioequivalence studies for generic and hybrid medicinal products in accordance with the regulatory requirements of the EAEU and the Russian Federation.

What Is Included?
✔ Development of the bioequivalence study design
✔ Preparation of the complete study documentation package
✔ Obtaining regulatory approvals and authorizations
✔ Selection of investigational sites and healthy volunteers
✔ Organization of the clinical phase of the study
✔ Bioanalytical testing of biological samples
✔ Statistical data analysis
✔ Preparation of the bioequivalence study report
✔ Support in compiling the registration dossier

Which products require bioequivalence studies?
Generic medicinal products
Bioequivalence studies are conducted to demonstrate that a generic medicinal product is comparable to the reference product in terms of the rate and extent of absorption of the active substance.
Hybrid Medicinal Products
Bioequivalence studies may be conducted as part of a comprehensive development and registration program for hybrid medicinal products to demonstrate their interchangeability with the reference medicinal product.

Upon Project Completion, the Client Receives:

• A bioequivalence study report;
• Statistical, analytical, and validation reports;
• A complete package of documentation for the registration dossier;
• Expert support during regulatory submission.

Our advantages:

✔ Proprietary clinical research center
✔ 13 years of experience conducting bioequivalence studies, including more than 6 years at our dedicated clinical facility, Serta Clinic
✔ In-house database of healthy volunteers
✔ Full project support throughout the entire study lifecycle, from protocol development to the final study report

Request a commercial proposal for registration services

We will assess the scope of work and prepare a commercial proposal within 1–3 business days.

We provide comprehensive pharmacovigilance services for clinical trials, ensuring compliance with GCP, EAEU, and Russian Federation regulatory requirements throughout the study lifecycle.

Our services Iinclude:
✔ 24/7 safety support and consultation
✔ Collection, processing, and assessment of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
✔ Preparation and submission of safety reports
✔ Preparation and management of Development Safety Update Reports (DSURs) for investigational medicinal products
✔ Communication and coordination with regulatory authorities
✔ End-to-end pharmacovigilance support for clinical trials

Our advantages:

✔ More than 350 completed projects
✔ More than 13 years of experience
✔ Proprietary Clinical Research Center with 42 inpatient beds
✔ In-house volunteer database
✔ Certified ISO 9001:2015 Quality Management System
✔ Experience working in Russia and EAEU member states

Request a commercial proposal for registration services

We will assess the scope of work and prepare a commercial proposal within 1–3 business days.

We provide comprehensive regulatory registration support for medicinal products, medical devices, and dietary supplements in the Russian Federation and EAEU member states (including Armenia), covering the entire process from dossier preparation to obtaining the registration certificate.

What Is Included?
Medicinal Products
✓ Development of a regulatory registration strategy
✓ Preparation of the registration dossier in CTD format
✓ Preparation of non-clinical and clinical overviews
✓ Development of the Summary of Product Characteristics (SmPC) and Package Leaflet (PL)
✓ User testing of the package leaflet
✓ Regulatory submission support and communication with regulatory authorities
✓ Obtaining the Marketing Authorization (Registration Certificate)

Medical Devices
✓ Development of a regulatory registration strategy
✓ Preparation of technical and operational documentation
✓ Organization and management of technical testing
✓ Organization and management of toxicological studies
✓ Obtaining authorization for clinical investigations
✓ Organization and conduct of clinical investigations of medical devices
✓ Preparation of the Clinical Evaluation Report and clinical investigation reports
✓ Regulatory submission support and obtaining the Registration Certificate

Dietary Supplements (Food Supplements)
✓ Composition review and registration feasibility assessment
✓ Preparation of the complete registration documentation package
✓ Preparation and submission of the registration application
✓ Coordination of laboratory testing and product evaluation
✓ Organization and conduct of clinical studies, where applicable
✓ Communication with expert organizations and regulatory authorities
✓ Full support throughout the registration process until obtaining the State Registration Certificate

Why choose us?

✔ More than 13 years of experience
✔ Proprietary Clinical Research Center
✔ Expertise in the registration of medicinal products, medical devices, and dietary supplements
✔ Turnkey project management and regulatory support
✔ Dedicated team of clinical research and regulatory affairs specialists

Request a commercial proposal for registration services

We will assess the scope of work and prepare a commercial proposal within 1–3 business days.