Regulatory Intelligence

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Written by: Ruslan Kuchumov
Category: Regulatory Intelligence
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Regulatory Intelligence is the technical library behind the Pharegis service practice. It brings the existing long-form articles into one navigable collection without replacing their established search URLs.

The library is organised by regulatory task rather than by publication date: medicinal products and lifecycle, GMP and inspections, medical devices, clinical and preclinical studies, regulatory consulting, and regulatory terminology.

Use the practice sections below to browse the full article set, or use site search for a specific regulatory term, procedure or jurisdiction.

Regulatory Intelligence

All technical articles

Long-form Pharegis regulatory guidance organised by practice area. Historical SEO URLs, publication dates and article content are retained.

Medicinal Products & Lifecycle

6 articles
EAEU · Registration

Drug Products Registration in Eurasian Economic Union and CIS

Medicinal product registration support in the EAEU: regulatory pathway, CTD dossier alignment, authority submission, market authorization and lifecycle planning.

 Russia · API / CMC

Registration of Active Pharmaceutical Ingredients (API) in Russia

API registration and CMC regulatory support in Russia, covering drug-substance documentation, manufacturing data, dossier preparation and lifecycle compliance.

 Russia / EAEU · Variations

Registration of Drug Dossier Variations in Russia and EAEU

Regulatory support for drug dossier variations in Russia and EAEU, covering change assessment, classification, documentation and lifecycle submissions.

 EAEU · Dossier harmonisation

Bringing National Drug Product Registrations into Compliance with Eurasian Economic Union (EAEU) Requirements

Guidance on bringing national medicinal product dossiers into compliance with EAEU requirements, including dossier conversion and regulatory strategy.

 Russia · Registration

Registration of Drug Products in Russia

Practical guidance and regulatory support for medicinal product registration in Russia, including dossier requirements, studies, quality control and authorization.

 Russia · Variations classification

Classification of Variations to Registration Dossiers for Drug Products (National Procedure — Russia)

Classification of changes to Russian national drug registration dossiers, with practical guidance on variation types, documentation and submission strategy.

GMP & Inspections

1 article
EAEU · GMP

EAEU GMP Certification

EAEU GMP inspection and certification support for pharmaceutical manufacturers, including readiness assessment, documentation, CAPA and inspection strategy.

Medical Devices

2 articles
EAEU · Registration

Registration of Medical Devices in the Eurasian Economic Union

Regulatory support for medical device registration and clinical evidence in Russia and EAEU, from classification and technical files to authorization.

 Russia · Certification / declaration

Certification of Medicinal Products and Medical Devices in Russia

Overview of certification and declaration requirements for medicinal products and medical devices in Russia, with regulatory support from Pharegis.

Clinical & Preclinical Studies

6 articles
Clinical · Registration

Clinical Studies for Medicinal Product Registration

Clinical study planning and execution for medicinal product registration in Russia, including regulatory requirements, submissions and study support.

 Clinical · Phase I / II

Phase I, Phase II (IIa, IIb) Clinical Studies

Regulatory and operational support for Phase I and Phase II clinical studies in Russia, from study planning and submissions to local execution.

 Clinical · Phase III

Phase III Clinical Studies in Russia

Regulatory and operational support for Phase I and Phase II clinical studies in Russia, from study planning and submissions to local execution.

 Preclinical · Medicinal products

Preclinical Studies for Registration of Pharmaceuticals in Russia

Preclinical study requirements and support for pharmaceutical registration in Russia, including program planning, documentation and regulatory strategy.

 Preclinical · Biopharmaceuticals

Preclinical Studies for Registration of Biopharmaceuticals in Russia

Preclinical study support for biopharmaceutical registration in Russia, including study strategy, documentation and regulatory requirements.

 Preclinical · In vitro

In vitro Preclinical Studies in Russia

In vitro preclinical study support in Russia for pharmaceutical development and registration, including regulatory planning and documentation.

Regulatory Consulting

1 article
Russia / EAEU · Strategy

Consulting on Pharmaceutical Regulatory Affairs and Registration Strategy

Senior regulatory strategy for pharmaceutical and healthcare products: pathway assessment, dossier gap analysis, risk planning and authority strategy.

Regulatory Glossary

1 article
Russia / EAEU · Terminology

Definitions used in Russian pharmaceutical regulations

Glossary of terms used in Russian and EAEU pharmaceutical regulation, registration, clinical research, quality and regulatory affairs.