Strategic Regulatory & Clinical Development Consulting

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