RJR Consulting
RJR Consulting is a global regulatory compliance consulting company servicing the life sciences industry, including pharmaceuticals, biologics, medical devices, IVDs, supplements, and cosmetics. They leverage in-country expertise to fulfill regulatory needs worldwide, providing services such as product registration, GMP compliance, licensing, labeling, and agency representation. Their network of in-country personnel ensures accurate, updated information and interface with healthcare authorities globally. RJR prides itself on exceptional client service, on-time delivery, and cost-effective solutions, helping clients navigate complex regulatory challenges across various markets.
Industries
Nr. of Employees
small (1-50)
RJR Consulting
154 E Main Street, New Albany, Ohio 43054
Services
End-to-end regulatory support for human and veterinary pharmaceuticals including clinical strategy, IND/NDA/BLA support, CTD formatting, dossier submissions, GMP/GCP inspection support, and pharmacovigilance.
Regulatory strategy and submission support for medical devices and IVDs including 510(k)/PMA submissions, EU MDR/CE marking, technical file review, ISO 13485/MDSAP compliance and risk management auditing.
Regulatory support tailored to biological products, including BLA submissions, GLP/GMP audit assistance, pre-clinical meeting preparation, clinical trial notifications and facility registration.
Classification and regulatory pathway determination for combination products, PMOA assessments, regulatory submissions coordination, and pre-submission meetings with regulators.
Ingredient evaluations, label and claims review, NDIN/new-ingredient assessments, advertising review against FDA/FTC guidance, and assistance with product registration where required.
Product classification, MOCRA and US compliance support, ingredient reviews (including state-specific requirements), facility/product listing, and labeling/marketing content review.
End-to-end regulatory support for human and veterinary pharmaceuticals including clinical strategy, IND/NDA/BLA support, CTD formatting, dossier submissions, GMP/GCP inspection support, and pharmacovigilance.
Regulatory strategy and submission support for medical devices and IVDs including 510(k)/PMA submissions, EU MDR/CE marking, technical file review, ISO 13485/MDSAP compliance and risk management auditing.
Regulatory support tailored to biological products, including BLA submissions, GLP/GMP audit assistance, pre-clinical meeting preparation, clinical trial notifications and facility registration.
Classification and regulatory pathway determination for combination products, PMOA assessments, regulatory submissions coordination, and pre-submission meetings with regulators.
Ingredient evaluations, label and claims review, NDIN/new-ingredient assessments, advertising review against FDA/FTC guidance, and assistance with product registration where required.
Product classification, MOCRA and US compliance support, ingredient reviews (including state-specific requirements), facility/product listing, and labeling/marketing content review.
Expertise Areas
- Regulatory compliance for pharmaceuticals and biologics
- Medical device and IVD regulatory affairs (EU and US pathways)
- Combination product regulatory strategy and classification
- Clinical trial regulatory support and submissions
Key Technologies
- CTD dossier preparation and formatting
- Regulatory intelligence and country-specific registration processes
- GMP and ISO 13485 quality system frameworks
- Pharmacovigilance systems and safety reporting processes
News & Updates
Trade show where RJR Consulting will discuss compliance needs.
Trade show where RJR Consulting will discuss compliance needs.
Trade show where RJR Consulting will discuss compliance needs.
Trade show where RJR Consulting will discuss compliance needs.