THE RIGHT FIT

At Opus, success is measured by the satisfaction of both our clients and consultants. We achieve this by strategically aligning the right experts with each project—tapping into our team of top-tier Regulatory Strategy, CMC, Labeling, Ad Promo and Med Review/Med Info experts. Our approach ensures the ideal expert is paired with every unique project need.

Filling the gaps

The work does not stop while you search for your permanent, full-time employee.

Functional outsourcing

Providing a flexible and nimble approach to sourcing all or part of a department.

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critical needs

We are ready to jump in to ensure business does not get interrupted when someone leaves unexpectedly.

 

Core services

 

Regulatory Strategy

Global Experience

  • Early through late stage development
  • Lifecycle management
  • Clinical trial planning and protocol review
  • Study start up consultation

Pathway Assessment

  • Orphan Design
  • Pediatric
  • Fast Track
  • Breakthrough therapy designation
  • Priority review and accelerated approval

Health Authority Prep

  • Pre-IND/CTA
  • End of Phase 2
  • Pre-NDA/BLA
  • Late-Cycle meetings
  • FDA Ad Comm
  • US and ex-US

Functional Leadership

  • Representing on cross-functional teams
  • Regulatory intelligence
  • Cutting edge knowledge of FDA guidelines
 

Regulatory CMC

CMC Strategy and Execution

  • Developing CMC strategy
  • Responsible for final content in CMC sections submitted to health authorities
  • Working in collaboration with key functional areas: Product Supply, Clinical/Non-Clinical

Global and Local Experience

  • Driving final content in CMC sections submitted to health authorities
  • Working in collaboration with key functional areas: Product Supply, Clinical/Non-Clinical

Health Authority Interactions

  • Lead interactions relative to CMC issues
  • Pre-IND
  • End of Phase 2
  • Pre-NDA
  • Late-Cycle Meetings
  • FDA Ad Comm

Functional Leadership

  • Representing CMC on cross-functional teams
  • Regulatory intelligence, relative to CMC
  • Cutting edge knowledge of FDA guidelines
  • Proactive identification of issues, escalation to management as appropriate
 
 

Labeling

End-To-End Development

  • Create and maintain core and regional labeling
  • CCDS, USPI, EU SmPC
  • Develop target labeling to support Phase 1 & 2
  • Ensure compliance through quality checks and tracking mechanisms
  • Draft labeling operating procedures and workflow

Leading Cross-Functionally

  • Provide insight and strategy to arrive at team consensus
  • Chair labeling committee meetings
  • Ensure strategic alignment for products

Health Authority Engagement

  • US and ex-US
  • Manage initial filing
  • Support Health Authority information requests
  • Preparation of labeling for submission to HA’s and/or subsidiaries worldwide

Tailored Labeling Education

  • Virtual or in-person sessions
  • Tailored content for your team
    • Core, US, EU, ROW, Target, Labeling Working Group Meetings, Labeling 101
  • Sessions presented by Senior Level Consultants accustomed to conference presentations
 
 

Ad Promo

Cross-Functional Education

  • Review and approval of all advertising and promotion materials
  • Early engagement with concept development
  • Branded, unbranded and disease awareness
  • Strategic, risk based reviews

Process Development

  • Procedure auditing
  • SOP drafting and review
  • Veeva implementing guidance
  • Training and mentoring of new hires

Health Authority Engagement

  • FDA Advisory Comments submission strategy and execution
  • 2253
  • Subpart H/E

Launch Planning

  • Implementation plan
  • Accelerated approval timeline
  • Safety doc drafting
  • Pre-approval communication guidance
 
 

Medical Review & Information

Comprehensive medical review & information

  • Content Review: Expert partnership in promotional and medical content reviews to ensure scientifically accurate content that meets regulatory requirements.
  • Medical Information: Ensuring HCPs and consumers receive the most accurate and up-to-date drug information to support healthcare decision making.
  • Scientific & Clinical Expertise: Providing in-depth clinical and scientific expertise to inform commercial and medical strategy.
  • Cross-Functional Collaboration: Synergistic partnership with cross functional teams to ensure an optimal content development process.
  • Process Optimization: Support in ensuring an efficient end to end content development process, and best practices tailored to your organization.
 

LET’S MAKE IT HAPPEN

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