INDUSTRIES
Regulatory Expertise Across Life Sciences
RJR provides life sciences regulatory consulting across pharmaceuticals, biologics, medical devices and IVDs, combination products, supplements and natural health products, and cosmetics. Regulatory pathways differ by product type, development stage, and market. We combine product-specific regulatory knowledge with in-country expertise to help clients define requirements, prepare submissions, maintain authorizations, and address compliance obligations across global markets.
PHARMACEUTICALS & BIOLOGICS
Life Sciences Regulatory Consulting for Pharmaceuticals & Biologics
RJR supports human and veterinary pharmaceutical, biologic, and biosimilar programs from early regulatory planning through registration and ongoing lifecycle maintenance. We coordinate product-specific strategy with the in-country knowledge needed to address the requirements and regulatory practices of each target market.
Strategy, Development & Registration
- Regulatory strategy and development planning
- Marketing authorizations and product registrations
- Drug Master Files, ASMFs, and VMFs
- Regulatory intelligence and health authority support
Compliance & Lifecycle Management
- GMP compliance and mock audits
- Labeling and packaging compliance
- License renewals and variations
- In-country establishment licenses and representation, where applicable
Medical Devices & IVds
Regulatory Support from Development Through Post-Market
RJR supports medical device and in vitro diagnostic (IVD) programs from early regulatory planning and product classification through registration and post-market compliance. We combine centralized project leadership with an affiliated network of in-country professionals to help clients interpret market-specific requirements, prepare submissions, coordinate health-authority interactions, and address in-country representation needs where applicable.
Development & Regulatory Submissions
- Regulatory strategy and product development planning
- Clinical Trial Dossiers and Investigational Device Exemption (IDE) applications
- FDA 510(k) and Premarket Approval (PMA) submissions
- EU MDR compliance, technical files, CE marking, and global Device/IVD registrations
Quality Systems & Post-Market Compliance
- ISO 13485, GMP, and MDSAP compliance and audit support
- Quality system assessments, risk management, and process validation
- Post-market surveillance, complaint handling, and regulatory maintenance
- US Agent, EU Authorized Representative, UK Responsible Person, and other in-country representation services
COMBINATION PRODUCTS
Regulatory Strategy Across Drug, Device, and Biologic Components
Combination products bring drug, device, and biologic requirements into a single program, while the applicable classification, lead authority, and approval pathway can vary by market. RJR applies life sciences regulatory consulting to help clients evaluate primary mode of action and constituent-part requirements, define a coordinated strategy, prepare documentation, and support health-authority interactions across target markets.
Classification & Regulatory Pathway
- Combination product classification and primary mode of action (PMOA) assessment
- FDA Request for Designation (RFD) and related meeting support
- Identification of lead regulatory authorities in target markets
- Interpretation of market-specific combination product requirements
Development, Submissions & Compliance
- Regulatory strategy and product development planning
- Pre-submission meetings and health-authority engagement
- Regulatory documentation and submission preparation
- Clinical trial notifications and Institutional Review Board (IRB) applications
- GMP requirements for applicable constituent parts
SUPPLEMENTS & NATURAL HEALTH PRODUCTS
Classification, Registration, and Compliance Across Global Markets
Regulatory treatment of supplements and natural health products varies widely by market, with classification often determined by ingredients, intended use, and product claims. RJR helps clients identify the applicable product category, assess ingredient and labeling requirements, prepare notifications or registrations, and address market-specific compliance and in-country representation needs where required.
Classification, Ingredients & Registration
- Product classification based on ingredients, intended use, and claims
- Ingredient review and regulatory compliance
- Notification and registration procedures across target markets
- Regulatory requirements and pathway assessment for target markets
Labeling, Claims & Market Compliance
- Labeling and packaging compliance reviews
- Review of product claims across labels, websites, and social media
- Authorized in-country representation where required
- Import and customs considerations in foreign markets
COSMETICS
Global Cosmetic Compliance from Classification Through Market Entry
Cosmetic requirements vary by market and may depend on product classification, ingredients, claims, labeling, testing, and manufacturer obligations. RJR helps companies assess these requirements, support U.S. MoCRA compliance, prepare international regulatory filings, review ingredients and labeling, and address US Agent representation for foreign manufacturers where applicable.
Classification, Ingredients & Regulatory Filings
- Global product classification based on ingredients and claims
- Ingredient compliance reviews
- Assessment of applicable U.S. state-specific requirements
- Regulatory filings with authorities in international markets
MoCRA, Labeling & Market Compliance
- U.S. MoCRA compliance
- Facility registration and product listing
- Labeling and packaging reviews, including professional-use and warning statement requirements
- Review of marketing, website, and social media content
- US Agent representation for foreign manufacturers
Discuss a Cosmetic Product Program
Next steps
Discuss Your Regulatory Program with RJR
RJR’s life sciences regulatory consulting combines product-specific strategy with coordinated in-country support for market entry, submissions, and ongoing compliance.