Global Regulatory Consulting
Industry leaders with comprehensive submission experience to strategically position your product.
Moving you to the next phase
Premier Consulting offers full-service strategic product development and global regulatory expertise in all stages of drug development. Their regulatory consultants are with you throughout the development of your drug, biologic, device, drug-device combination, or diagnostic product. Their regulatory consulting services include:
- Extensive experience with agency interactions, averaging 75-plus meetings per year
- Consulting services aligned with agency thinking on drug/biologics/device development requirements
- Functional services such as acting head of regulatory for start-up companies
- Preparation and review of clinical protocols, CMC amendments, and response to agency questions
- Commercial solutions that maximize the potential of your program throughout development and the commercial lifecycle
- Publishing and document management experience, including significant work with new drug applications, biologics license applications, marketing authorization applications, and rest-of-world submissions
- eCTD submission process and expertise at every step of the approval process
From discovery through post-marketing, Premier Consulting supports strategy, trial design, regulatory submission, and compliance and has extensive experience preparing customers for major submissions and agency meetings.
The experienced Premier Consulting team can develop your:
- Strategic development plans
- FDA meeting preparation
- Nonclinical program
- IND and marketing application preparation and submission
- Orphan drug, breakthrough, and fast-track applications
- Clinical study design
- Clinical study reports
- Global safety database design
- SAE reporting
From early-phase to late-stage development, Premier Consulting’s global product development team leaders synchronize multidisciplinary services, global development expertise, and insight from therapeutic thought leaders to create development strategies custom-fit to your needs.
- Development planning
- Regulatory agency strategies and IND maintenance
- Study design to whole development plans
- Infrastructure expertise
- Data analysis and handling
- Product/company safety database
- Preferential regulatory pathways
- Regional legal representation
- Orphan applications
- Accelerated or breakthrough planning
Expedited drug development in the U.S. & Europe
Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It’s essential to start with the end firmly in mind, identifying the target population and defining elements of the program long before you dose the first patient.
Changes in India’s drug and clinical trial rules
One reason for the slow growth of clinical research in India has been the country’s stringent regulatory requirements. The Ministry of Health and Family Welfare, responsible for all health policy in India, took steps to clarify these requirements and address many of sponsors’ concerns with the publication of its New Drugs and Clinical Trials Rules in 2019.
Global Regulatory Consulting Experts
Shari Medendorp, MPH
Adding value at every step in the process, we provide expertise in strategic product development, clinical R&D, and technology tools to ensure your trial’s data integrity, process efficiency, and timely analytics and reporting.
Strategic Product Development
Clinical Research & Development
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