Industry leaders with comprehensive submission experience to strategically position your product.
Moving you to the next phase
Regulatory professionals who guide you throughout your study
Regulatory Professionals, A Division of Premier Research, offer full-service strategic and tactical product development expertise in all stages of drug development. Our regulatory consultants are with you throughout the development of your drug, biologic, device, drug-device combination, or diagnostic. Our regulatory consulting services include:
- Extensive experience with agency interactions, averaging 20-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 of and review of clinical protocols, CMC amendments, and response to agency questions
- 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 Phase 1 through post-marketing, we support trial design, regulatory submission, and compliance and have extensive experience preparing customers for major submissions and agency meetings.
Our experienced team can develop your:
- Strategic development plans
- FDA meeting preparation
- IND preparation and submission
- Orphan drug, breakthrough, and fast-track applications
- Study design
- Clinical study reports
- Global safety database design
- SAE reporting
From early-phase to late-stage development, our 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
PREMIER INSIGHT 268
Six months to submission
The client asked the nearly impossible – a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it.
Four common IND mistakes
Before starting Phase 1 trials, an investigational new drug application must be approved by the FDA. This critical step grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval.