Global Regulatory Consulting for Life Sciences Companies
Built on In-Country Expertise
RJR Consulting provides global regulatory consulting for life sciences companies managing regulatory requirements across global markets—from strategy and product registration to ongoing compliance and in-country representation. We combine centralized project leadership with an affiliated network of in-country regulatory professionals to provide market-specific guidance, current regulatory intelligence, and coordinated support in working with health authorities worldwide.
Global Regulatory Consulting by Industry
Regulatory pathways vary by product type, stage of development, and market. RJR brings together the product-specific and in-country expertise required for each assignment.
Pharmaceuticals and Biologics
Regulatory strategy, development support, submissions, registrations, and lifecycle maintenance for human and veterinary pharmaceuticals, biologics, and biosimilars.
Medical Devices and IVDs
Market-entry strategy, product registrations, quality-system support, and in-country representation for medical devices and IVDs across global markets.
Combination Products
Coordinated regulatory support for products that combine drug, biologic, and device requirements—from classification and development planning through submission.
Supplements and Natural Health Products
Market-specific support for product classification, ingredient compliance, labeling, claims, notifications, registrations, and in-country representation.
Cosmetics
Market-specific regulatory support for cosmetic product classification, ingredient requirements, labeling, claims, notifications, and registrations.
How rjr supports clients
Regulatory and Quality Capabilities
RJR coordinates the regulatory, quality, and in-country expertise clients need to bring products into global markets and maintain regulatory compliance.
Strategy & Intelligence
- Regulatory Strategy Development
- Regulatory Intelligence
- Product or Market Research
Registration & Maintenance
- Marketing Authorizations & Product Registrations
- License Renewals & Variations
- Drug Master Files, ASMFs & VMFs
Quality & Compliance
- GMP Compliance & Mock Audits
- ISO 13485 & MDSAP
- Labeling & Packaging Compliance
In-Country Support
- In-Country Establishment Licenses
- Local Affiliations & Partnerships
- Agency Regulatory Affairs Representation
- Authorized or Legal In-Country Representation
Coordinated Across Markets
One Regulatory Relationship. Market-Specific Expertise.
Regulatory work across multiple markets can quickly become fragmented. RJR provides centralized project leadership while coordinating the in-country expertise required for each jurisdiction—giving clients continuity across markets without requiring them to identify and manage a separate consulting provider for every assignment.
RJR-Led Coordination
RJR defines the assignment, establishes responsibilities and timelines, and coordinates communication across markets—giving clients a consistent point of contact and clear visibility into the work.
In-Country Expertise
RJR coordinates professionals familiar with local requirements, regulatory practices, and health authority expectations, adapting execution to each jurisdiction’s needs.
regulatory developments
Latest Regulatory Insights
RJR monitors regulatory developments across global markets to help clients understand what is changing, where it applies, and what may require action.
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Saudi FDA Issues Guidance on Medical Device Bundling
Saudi FDA medical device bundling MDS-G28 explains when device groupings may share one MDMA application and when separate submissions are needed.
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Malaysia and Thailand Implement Medical Device Regulatory Reliance Programme
Malaysia–Thailand medical device reliance supports Class B, C, and D registrations through streamlined pathways between MDA and Thai FDA.
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Chile Expands Sanitary Control for Medical Devices and IVDs
Chile medical device registration expands to 39 higher-risk devices and IVDs under Decree No. 25, with phased compliance through the ISP.
define the next step
Tell Us About Your Product, Markets, and Regulatory Objective.
Whether you are preparing to enter a new market, maintain an existing authorization, or respond to a changing requirement, RJR can help determine what is required and coordinate the appropriate expertise.