Executing all of the activities needed to move an asset into clinical development and creating a development plan that increases the success of product approval requires specialized, cross-functional expertise. Our integrated team of experts including physicians, scientists, regulatory professionals, and biostatisticians has the experience to help you effectively plan for and overcome any challenges your product may face from discovery through approval. With wide-ranging, pre-clinical and therapeutic expertise, our regulatory and clinical development consulting team can develop customized plans that increase efficiency, reduce risk, and maximize your product’s value.
We Can Help You
Identify your target product profile (TPP)
Understand and create a strategy to address the global regulatory requirements for your product
Define your toxicology and chemistry, manufacturing and controls (CMC) strategies
Identify relevant regulatory designations to expedite product review and approval
Determine if there are pharmacology and toxicology issues unique to your product
Navigate the drug development process, including designing the studies strategically to maximize your investment for both approval and access
Develop and optimize study protocols for efficiency and data collection
Identify opportunities to reduce costs and improve efficiency of clinical trials through the design and execution of innovations such as adaptive designs
Engage early with multiple stakeholders for insight into your development planning
Develop and implement strategies for assets with unique challenges, such as rare diseases, cell and gene therapies, medical devices, biosimilars
Conduct portfolio reviews to evaluate the commercial value of products in development to support asset decisions
We Offer You
Strategic Regulatory Solutions & Insights Including:
Development of both global and regional regulatory strategies
Deep expertise in the design and management of programs
Comprehensive knowledge in the preparation of regulatory and filing submissions, including Investigational New Drug/Clinical Trials Application (IND/CTA) preparation and filing
Customized strategies and development plans for pre-IND assets
Support and management of all aspects of CMC development
Development of comprehensive, pre-clinical toxicology plans
Insight to determine the appropriate legal status for products
Vital discovery phase activities including determining activity, dose, and schedule and assessing safety and pharmacology
Facilitation of ongoing relationships with regulators to ensure compliance
Selection of the right external vendors to fit your project needs
Clinical Development Services Including:
Direct access to industry-leading experts in the design and execution of full product development programs, including regulatory considerations
Deep expertise across all major therapeutic areas
Close consultation to develop customized plans that increase efficiency
Customized services for small and large molecules, devices, cellular and gene therapies, and companion diagnostics
Specialized regulatory and development guidance for virtual entities and small or emerging biotechnology companies
Gap assessment in strategic resourcing, enhancement of existing resources, or engagement in longer-term planning activities for larger biotechnology or pharmaceutical companies
Options for study-specific projects or full partnerships in supporting your entire portfolio of assets
Integrated scientific advice for evidence generation optimization for both regulatory and market access
Experienced Regulatory Consulting Experts
Our dedicated regulatory consulting team brings decades of experience in supporting clients with deep knowledge of regulatory needs, including:
- Toxicologists with over 50 years combined experience in drug development
- Expertise across a wide range of product types including:
- Small molecules
- Oligonucleotides
- Peptides
- Biologics
- Therapeutic proteins
- Immunoconjugates
- Vaccines
- Biosimilars
- Advanced therapies (cell, gene, etc.)
- Reformulations/liposomal
- Line extensions
- New markets
- Experience across multiple routes of administration including:
- Oral
- Parenteral (IV/IM/SC)
- Inhalation
- Topical (dermal/ocular)
- Other specialty area expertise including:
- Drug metabolism
- Safety pharmacology
- Impurity assessment
- Excipient evaluation
- Extractables/leachables
Deep Clinical Development Expertise
Our clinical development experts bring varied backgrounds and decades of experience to support your clinical development needs, including:
- Consultants with prior FDA and EMA experience
- Direct access to industry-leading experts in the design and execution of full product development programs
- A full range of strategic and operational expertise, including specialty areas such as:
- Cell and gene therapy
- Rare diseases
- Designations such as orphan, breakthrough, PRIority Medicines (PRIME), pediatric rare disease, regenerative medicine, and advanced therapy
- Pediatrics
- Immuno-oncology
- Biosimilars
- Medical devices and diagnostics
- Translational medicine
Strategic Regulatory & Clinical Development Consulting Resources
Strategic Regulatory Clinical Development Consulting Experts
