01

Investment Counselling

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

02

Development Strategy Elaboration

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.)

03

Design, Analysis, and Interpretation of Studies/Trials

Design, analysis, and interpretation of studies/trials. Audit/validation of analyses conduct by other biostatisticians. Complex designs: high variability and widening of bioequivalence/biosimilarity margins, adaptive designs, factorial designs, multi-cohort and multiple comparisons, missing data, baseline covariates, stratification, iterative sample size estimation, power planning, ANOVA, modeling & simulations

04

Designing Non-clinical Tests and Clinical Trials

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

05

Procedural Counselling

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

06

Orphan Medicinal Products, Conditional Approval, Breakthrough Therapy

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

07

Interim Analyses of Clinical Trials Data

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

08

Integrated Counselling on the Development Status

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

09

Counselling on EAEU Legislation

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

10

Medical Writing, Including Non-clinical and Clinical Overviews

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

11

Assessment, Review, and Refinement of Non-clinical and Clinical Documentation

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

12

Elaboration of Scientific, Legal, and Procedural Justifications and Other Accompanying Documents

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

13

Initial Counselling on Entering Extensively Regulated Markets

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

14

Scientific Support of Acquisitions of Investigational Medicinal Products Developed Abroad

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

15

Counselling on Complex Issues: Biological Products, Nanomedicines, Advanced Therapy Medicinal Products, Biomedical Cell Products

Counselling on complex issues related to development, manufacturing, quality control, non-clinical tests and clinical trials and approval of complex / specific medicinal products: biological medicinal products, nanomedicines (liposomes, nanocrystals, etc.), advanced therapy medicinal products, biomedical cell products, non-biologic complex drugs (glatiramoids, colloidal iron, etc.)

16

Scientific and Regulatory Advice to Applicants Developing Responses on Observations of Regulatory Authorities

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.

17

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

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

18

Naming of Medicinal Products

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

19

Labelling

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

20

Bioavailability, Bioequivalence and Biowaivers, Post-approval Changes

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