Opus Regulatory
Opus Regulatory is a niche Regulatory Affairs consulting firm providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Their clients range from development stage biotech companies to mid-size and large pharmaceutical companies. The team is made up of biopharmaceutical leaders and innovators dedicated to providing high-level regulatory consulting services, with a mission to exceed client expectations. They value experience, integrity, and a client-centric approach, emphasizing core values such as passion, excellence, integrity, respect, and accountability.
Industries
Nr. of Employees
small (1-50)
Opus Regulatory
Products
Promotional Review Fundamentals – Team Registration (5–9)
Instructor-led virtual training program focusing on promotional review fundamentals, offering group registration savings for teams of 5 to 9 participants.
Insights: Global Regulatory Labeling
A comprehensive two-day labeling education symposium exploring fundamental labeling skills, specialized concepts, current events, and new regulatory initiatives, hosted by Opus Regulatory through its Opus Insights education arm.
Opus Insights: Global Regulatory Labeling Workshop
A comprehensive labeling education symposium hosted by Opus Regulatory exploring fundamental labeling skills, specialized concepts, current events, and new regulatory initiatives.
Regulatory Strategy Consulting
Expert regulatory strategy consulting services provided by biopharmaceutical leaders to support clients at any stage of development.
Medical Review & Medical Information Services
Pharmaceutical medical review services and medical information services for biopharmaceutical companies.
Advertising and Promotion Consulting
Pharmaceutical advertising promotion consulting and promotional review consulting services.
Promotional Review Fundamentals – Team Registration (5–9)
Instructor-led virtual training program focusing on promotional review fundamentals, offering group registration savings for teams of 5 to 9 participants.
Insights: Global Regulatory Labeling
A comprehensive two-day labeling education symposium exploring fundamental labeling skills, specialized concepts, current events, and new regulatory initiatives, hosted by Opus Regulatory through its Opus Insights education arm.
Opus Insights: Global Regulatory Labeling Workshop
A comprehensive labeling education symposium hosted by Opus Regulatory exploring fundamental labeling skills, specialized concepts, current events, and new regulatory initiatives.
Regulatory Strategy Consulting
Expert regulatory strategy consulting services provided by biopharmaceutical leaders to support clients at any stage of development.
Medical Review & Medical Information Services
Pharmaceutical medical review services and medical information services for biopharmaceutical companies.
Advertising and Promotion Consulting
Pharmaceutical advertising promotion consulting and promotional review consulting services.
Services
Advisory services to define global regulatory strategies, pathway assessment and lifecycle planning across development stages.
CMC strategy development and drafting/finalization of CMC submission content with cross-functional collaboration.
Creation and maintenance of core and regional labeling, development of target labeling for early phases, quality checks and submission preparation.
Cross-functional review and approval of promotional materials, risk-based review processes, and regulatory submission strategy for promotional communications.
Procedure auditing, SOP drafting/review, and guidance for implementing regulatory content management systems; includes training and mentoring.
Provision of interim consultants or teams to fill regulatory roles, manage projects, or operate as part of a client's functional team.
Advisory services to define global regulatory strategies, pathway assessment and lifecycle planning across development stages.
CMC strategy development and drafting/finalization of CMC submission content with cross-functional collaboration.
Creation and maintenance of core and regional labeling, development of target labeling for early phases, quality checks and submission preparation.
Cross-functional review and approval of promotional materials, risk-based review processes, and regulatory submission strategy for promotional communications.
Procedure auditing, SOP drafting/review, and guidance for implementing regulatory content management systems; includes training and mentoring.
Provision of interim consultants or teams to fill regulatory roles, manage projects, or operate as part of a client's functional team.
Expertise Areas
- Regulatory strategy and pathway assessment
- CMC strategy and regulatory CMC interactions
- Labeling development and lifecycle management
- Advertising and promotion compliance
Key Technologies
- Regulatory submission preparation for IND/CTA/NDA/BLA
- Regulatory content management systems
- Label authoring and template management
- Regulatory intelligence frameworks
News & Updates
Opus Regulatory's team will be exhibiting at the 2025 DIA Global Labeling Conference in Arlington, VA.
Opus Regulatory team is attending the 2025 DIA Global meeting in Washington, DC.
Developed and presented in partnership with Opus Regulatory, exploring labeling and regulatory topics in Washington, DC.
Opus Regulatory is a sponsor for the 6th Annual Promotional Review Summit in Philadelphia.
Opus Regulatory's team will be exhibiting at the 2025 DIA Global Labeling Conference in Arlington, VA.
Opus Regulatory team is attending the 2023 DIA Global Annual Meeting in Boston.
Opus Regulatory's team will be exhibiting at the 2025 DIA Global Labeling Conference in Arlington, VA.
Opus Regulatory team is attending the 2025 DIA Global meeting in Washington, DC.
Developed and presented in partnership with Opus Regulatory, exploring labeling and regulatory topics in Washington, DC.
Opus Regulatory is a sponsor for the 6th Annual Promotional Review Summit in Philadelphia.
Opus Regulatory's team will be exhibiting at the 2025 DIA Global Labeling Conference in Arlington, VA.
Opus Regulatory team is attending the 2023 DIA Global Annual Meeting in Boston.