Evaluation of druggability of a proposed investigational product/new chemical entity, including early stages of development, based on their characteristics and proposed principle of action; preliminary audit of data generated; assessment of an overall development strategy against current requirements (Russia, EAEU, EU); milestones establishment

Determination of extent and succession of non-clinical tests and clinical studies as well as missing pharmaceutical and biologicals testing data; selecting a reference product; description of critical design elements of pivotal trials (superiority, non-inferiority, equivalence, etc.)

Development of the biostatistical section of clinical trial protocols and review of existing documents prepared by third parties. Preparation of justifications and supporting documents for regulatory authority interactions. Sample size estimation, including for studies with complex designs and interim analyses.

Innovator/original products, including early development issues (both chemical and biological/immunological drug substances), generic or hybrid medicinal products, biosimilars, herbal/botanical products, line extension applications

Compiling a marketing authorization dossier in accordance with Common Technical Document format; counselling on a legal basis of authorization, authorization procedure, reference product, reference Member State

Substantiating of orphan designation, justification for an abridged development program; design and analysis of trials on small populations; justification for a conditional approval; post-marketing development planning; adaptive pathways for development; scientific and procedural support of breakthrough therapy designation

Conducting an interim analysis of an ongoing clinical trial where prespecified; participation in Independent Data Monitoring Committee

Evaluation of adequacy of a marketing authorization dossier / clinical trial application in terms of non-clinical/clinical data needed and its quality; correlation between (non-)clinical and pharmaceutical data at any development stage and generating recommendations for gap filling; describing a real situation; assistance with further development strategy depending on approval scenario or post-approval life cycle

Procedural and scientific counselling on marketing authorization and CTA procedures envisaged by the law of the Eurasian Economic Union. Assistance with the optimal marketing authorization / bringing into compliance pathway

Medical writing of clinical trial and non-clinical tests protocols, clinical study reports, Investigator’s Brochures, case report forms, informed consent forms, non-clinical and clinical overviews (Modules 2.4 and 2.5), non-clinical and clinical summaries (Modules 2.6 and 2.7), drafting scientific justification of various claims

Assessment and refinement of non-clinical or clinical study protocols; assessment and refinement of non-clinical or clinical study reports; assessment and refinement of Investigator’s brochures, case report forms, informed consent forms, non-clinical and clinical overviews (Modules 2.4 and 2.5); assessment and refinement of non-clinical and clinical summaries (Modules 2.6 and 2.7), evaluation and elaboration of scientific justification of various claims

Elaboration of scientific, legal, and procedural justifications and other accompanying documents related to different claims made by a sponsor, manufacturer, applicant, or marketing authorization holder (i.e. where waiver of some studies is claimed) in view of streamlining the development program, eliminating unnecessary or redundant investigations and tests; reducing the timelines of authorization and decision-making procedures for marketing authorization applications and clinical trial applications

Initial counselling on entering the pharmaceutical markets of the European Union Member States, United States, Canada, Switzerland, etc. Description and explanation of the overall regulatory system, key milestones of development, assessment, and approval; initial drafting of a development and approval strategy

Scientific support of acquisitions of products developed abroad at any stage of development: verification of non-clinical and clinical data generated

Consulting on complex issues related to the development, manufacturing, quality control, non-clinical and clinical studies, as well as the marketing authorization of complex medicinal products, including nanomedicines (liposomes, nanocrystals, etc.), non-biologic complex drugs (glatiramoids, colloidal iron, etc.), inhalation products, locally applied products (ointments, creams, gels)

Consulting on the development, manufacturing, quality control, non-clinical and clinical studies, and marketing authorization of biological medicinal products, advanced therapy medicinal products, CAR-T products, gene therapy, oncolytic viruses, biomedical cell products, genome editing (CRISPR) techniques

Scientific and regulatory advice to applicants developing responses on observations of the regulatory authority: interpretation and explanation of assessors’/regulatory authorities’ observations, developing response strategy, elaboration and justification of applicant’s/marketing authorization holder’s position.

Scientific and Regulatory Support of Applicants on meetings with assessors/Ministry of Health officers devoted to specific aspects of development or approval

Assessment of acceptability of an invented name from the perspective of Russian / Eurasian Economic Union regulatory authorities.

Drafting, proofreading/refinement of documents related to product labelling: summary of product characteristics, patient leaflet, package label, medication guide, etc. Observation of Russian and/or Eurasian Economic Union requirements

Bioavailability evaluation, planning of bioavailability and bioequivalence studies, assessment of bioavailability and bioequivalence study reports, planning of bioequivalence demonstration depending on a pharmaceutical dose form, release mechanisms, internal and external factors and target population, etc. Determining feasibility and justification of biowaivers, scientific justification of abridged clinical development program

Consulting on the planning, execution, and reporting of studies for generating RWD and RWE. This includes assessing study feasibility, ensuring compliance with regulatory requirements, and utilizing these data for regulatory decision-making.

Consulting on the design and maintenance of disease and product registries, and the registry analysis data; planning and conducting registry-based studies; providing assistance in setting up data management systems; participating in steering committees; and planning data collection and analysis, etc.

Consulting on issues related to the planning and design of innovative design studies, including platform, basket and umbrella trials. Development of clinical trial documents for studies utilizing such innovative designs.