Let’s Move Your Program Forward. Together.
Wherever you are on your development journey, Premier Consulting’s cross-functional team of experts can help you reach your next milestone.
Regulatory
From concept to submissions to health authority interactions, we offer a full range of global regulatory support.
Nonclinical Services
Our nonclinical strategy and execution services help you reach critical development milestones on time and within budget.
CMC
Our experts advise on everything from formulation to site inspection protocol design from the earliest stages of your program.
Project Management
Our project managers serve as the single point of contact for all stakeholders throughout your project lifecycle, with a streamlined and customized approach.
Medical & Regulatory Writing
We have extensive experience supporting submissions compliant with both regional healthcare authority requirements and global guidelines.
Clinical Pharmacology and PK
We identify your needs and deliver integrated clinical pharmacology, pharmacokinetic, and bridging strategies to streamline overall development.
Regulatory and Development Support for Every Phase
We are scientists, researchers, strategists, and innovators on a mission to help biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments, devices, and diagnostics.
Premier Consulting provides strategic product development and global regulatory consulting services with unparalleled nonclinical, CMC, quality, clinical, and commercial expertise. We offer end-to-end strategic insights to help biotech companies advance their programs through every development milestone, from the earliest stages of strategy and planning, through regulatory approval, to commercialization.
Across the development lifecycle, our integrated solutions and cross-functional team provide customized support for your program. Providing a full range of strategic support, we help sponsors navigate their programs confidently and gain regulatory approval in the most cost- and time-efficient way possible.
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Regulatory Affairs and Operations
We offer a full range of regulatory support services, from product concept to submissions to regulatory interactions. We thoroughly analyze the issues associated with your unique program and assess the regulatory environment, acting as either an extension of your in-house regulatory team or your full-service regulatory department depending on your needs. With our help, you can approach regulators with confidence — minimizing risk and negotiating from a position of knowledge and strength.
Our Experts Can Help You with:
- Health authority interactions
- Global clinical trial applications
- Global marketing applications for drugs, biologics, and MedTech
- 505(b)(2) and innovative product planning and submissions
- Gap analyses, risk assessments, and target product profiles
- Compiling and publishing of regulatory/eCTD submissions
- Special designation requests
- And more!
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Whatever your regulatory needs are, Premier Consulting’s team can help to advance your product to the next phase of development. Find out more about how we can support your program!
Nonclinical Services
By delivering integrated nonclinical strategies, we get you to the clinic faster and support your continued clinical development. When you partner with Premier Consulting for your nonclinical program, you can reach critical development milestones on time and within budget.
Our Experts Can Help You with:
- Assessment of nonclinical development options, including IND-enabling studies
- Pre-submission meeting planning and execution
- Compliant nonclinical study design and execution, including contracting, monitoring, troubleshooting, and reporting
- Regulatory submission writing and review
- And more!
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Our experienced team of nonclinical experts can advance and streamline your program, from its earliest stages into clinical development and beyond. Contact us to discover how we can partner with you!
CMC
Since early planning in product development can save you significant time and money, our experts advise on everything from formulation to site inspections to protocol design from the earliest stages of your program. We have managed numerous successful CMC dossier submissions for clinical trial and marketing applications, and our network of CMOs allows us to identify the most suitable service providers for you.
Our Experts Can Help You with:
- Drug product development, including API and excipient sourcing, analytical development, and formulation development
- Manufacturing oversight for clinical trial material
- Supply-chain and manufacturing strategy, including technology transfers and vendor and facility selection
- Quality and compliance, including risk assessments and quality management system development
- CMC regulatory, technical, and document review
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Connect with our regulatory affairs and technical services experts to find out how they can ensure optimal performance for your CMC program, within time and budget parameters.
Project Management
We prepare programs for success from concept to market, serving as the single point of contact through the entire regulatory project lifecycle. Our project managers strategically position and guide clients through a streamlined and customized approach that helps them achieve their drug development goals, leveraging elevated tools such as SmartSheet timelines and Dashboards.
Our Experts Can Help You with:
- Cross-functional team coordination
- Development plan creation, from early development through commercialization
- Risk identification and management
- Management of document transfers, team meetings, administrative tasks, project finances, and timelines
- Health authority and third-party vendor interactions
- And more!
Contact us to find out how we can support your program!
Medical and Regulatory Writing
We provide medical writing and editing services for a wide variety of regulatory documents, ranging from health authority interaction submissions through post-marketing commitments. Familiar with regional healthcare authority requirements, ICH and GCP guidelines, and best industry practices, our writers have extensive experience supporting both single-document and large-scale submissions in eCTD format.
Our Experts Can Help You with:
- Regulatory/health authority submission documents
- Clinical trial and marketing application modules
- Clinical documents
- Document quality control and data integrity
- Protocols and protocol amendments
- And more!
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Our writers can support your next medical or regulatory submission, no matter what phase of development you are at or which global health authority you are submitting to. Reach out to learn more!
Clinical Pharmacology and PK
We identify crucial clinical pharmacology needs and deliver integrated clinical pharmacology, pharmacokinetic, and bridging strategies to move you efficiently through clinical development, while avoiding unnecessary and costly studies. Partner with us for your clinical pharmacology program to streamline overall development and meet critical milestones.
Our Experts Can Help You with:
- Clinical design strategy and protocol development, including bioavailability and bioequivalence, dose-ranging, drug-drug interactions, and special populations
- Strategic assessments and critical issue resolution
- Pre-submission meeting planning and execution
- 505(b)(2) strategy and design, including scientific bridging study design, cross-study literature comparisons, and biowaivers
- PK and PD analysis, modeling, and simulation
- CMC support
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Contact us to learn how our clinical pharmacology and PK expertise can support your program!
To discover how these and other Premier Consulting solutions can advance your drug, biologic, or device to the next phase of development, contact us today!
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