Instem Catalyst
Scientific and Regulatory Consulting to Strengthen Your R&D Workflows
Instem Catalyst gives you flexible access to experts who help you achieve operational efficiency, maintain compliance, and maximize the value of your workflows, irrespective of your technology choices. The portfolio spans a wide spectrum, from strategic and advisory consulting to ensuring you get full value from your software solutions.
Contact our experts today to tackle complexity with confidence and minimize risk across your workflows.
What is Instem Catalyst?
Instem Catalyst is a scientific and regulatory consulting service that provides specialist, product-agnostic guidance to support success from early discovery through IND submissions and beyond. Instem experts evaluate your strategic and operational needs, then provide targeted support and domain expertise to close critical gaps. The result is more efficient operations, reduced risk, and optimized project delivery.
Instem Catalyst is a turnkey approach, giving you access to the right expertise when you need it, and the ability to scale back when you don’t. Through flexible engagement models, Instem Catalyst helps pharmaceutical, biotech, medtech, manufacturing, CRO, and emerging organizations to stay agile, maintain continuity, and deliver with efficiency and confidence.
Key Benefits of Instem Catalyst
Reduces Risk
Access to on-demand experts helps address issues and optimize workflows quickly, reducing the risk of non-compliance and operational disruption.
Effective Scaling
Outsourced staffing enables teams to scale up or down as needed, responding quickly to changing demands.
Saves Time
Our experts help you make the right implementation choices from the start, saving you time and ensuring optimal workflow efficiency.
Vendor Agnostic
We are dedicated to your success and help you optimize your workflows whether you use Instem products or those of other vendors.
Improves Adoption
Instem Catalyst supports effective adoption of Instem solutions and helps demonstrate value to align key stakeholders.
Saves Resources
Instem Catalyst helps you maximize the value of your existing software and personnel while reducing the total cost of ownership.
Improves Compliance
We support clients in achieving regulatory compliance, including ISO certification, GxP requirements, and the data traceability enabled by Instem software solutions.
Core Features
Instem Catalyst spans a broad set of capabilities, combining expert resourcing with strategic, technical, and operational support across your organization and software ecosystem.
Strategy and Advisory
Expert assessment of processes, systems, data, and goals to identify gaps, define priorities, and create actionable plans that support informed decisions, strategic use of existing data, and long-term operational success.
Implementation and Modernization
Practical support to digitize processes, implement new platforms, migrate data, and modernize legacy workflows while minimizing disruption and improving day-to-day operational efficiency.
Validation and Compliance
Expert support for regulated systems, helping teams plan, document, test, and maintain validated environments that align with global regulatory and quality requirements, including GxP, 21 CFR Part 11, EU Annex 11, ISO standards, and other applicable international regulations.
Adoption and Optimization
Ongoing support to improve solution use, enhance user confidence, and uncover opportunities for greater efficiency, maximizing the long-term value of existing systems and future investments.
Resourcing and Managed Services
Flexible access to specialist expertise, FTEs or augmented staff, and managed support that helps teams maintain continuity, fill capability gaps, scale capacity, and keep critical projects moving forward.
Why Choose
Instem Catalyst?
Fluctuating personnel and technology demands can strain internal teams, increase costs, and delay projects. Building in-house capability is not always efficient, especially when support is only needed temporarily or at specific development stages.
Instem Catalyst gives you flexible access to heavily vetted experts with decades of consulting, scientific, technical, validation, project management, and operational experience. Our specialists embed within your team, working within your SOPs to help you respond quickly to evolving demands. They bring broad industry insight, practical solutions, and fresh perspectives to complex challenges.
Their first-hand knowledge of Instem products alongside deep technological and scientific expertise means they are perfectly positioned to help drive success, while a vendor-agnostic approach allows you to benefit from Instem Catalyst whether or not you use Instem software.
How It Works
Our approach is designed to quickly provide the right expertise for your team and deliver value from day one.
Needs Assessment and Resource Alignment
We take a highly collaborative approach, working with you to discuss your needs and expectations, ensuring alignment and identifying opportunities for improvement.
Embedded Delivery
Our specialists integrate seamlessly into your workflows, providing hands-on support across software implementation and validation, project management, and operational activities.
Flexible Scaling and Adaptation
As your needs evolve, we adjust resourcing and focus areas to ensure continued alignment with your priorities and timelines.
Ongoing Support and Continuity
We provide continuous access to expertise, ensuring stability, knowledge retention, and the ability to respond quickly to new challenges.
Frequently Asked Questions
Our flexible approach adapts to your needs. Below are answers to common questions about how we support your teams and delivery goals.
What if our requirements change during the project?
We provide flexible, on-demand access to expertise, allowing you to scale support up or down and adjust focus areas as your needs change.
How do you make sure you understand our end-to-end needs?
We begin with a collaborative discovery process that explores your people, processes, systems, data, compliance requirements, and long-term goals. This helps us identify gaps, dependencies, risks, and opportunities across the full workflow so we can recommend the right level of support.
How do you ensure the final solutions meet our needs?
We work with you to review, test, and refine each solution throughout the engagement. Our consultants gather feedback, make adjustments, and finalize deliverables only when they align with your expectations, operational needs, and success criteria.
Will the business discovery be product agnostic?
Yes. Business discovery is product agnostic and focused on your operational needs, challenges, and desired outcomes. Our goal is to help you make informed decisions, whether the right path involves Instem solutions, third-party systems, existing tools, or a combination of technologies.
How can we ensure the consultants assigned to us know and follow our SOPs?
Our consultants are introduced to your processes, systems, and SOPs before the engagement begins and continue to align with them throughout delivery. They work within your established procedures, documentation requirements, and quality expectations, while bringing relevant domain expertise to support compliant and consistent delivery.
Do you have fixed consulting offerings, or can you tailor an offering to our needs?
Both. Instem Catalyst includes defined consulting offerings, but engagements can also be tailored to your specific goals, timelines, systems, and resource needs. We can provide targeted support for a defined project or create a flexible model that evolves with your organization.
What do you need from us? How much involvement is required on our end?
Your involvement depends on the engagement, but we typically need access to key stakeholders, relevant documentation, systems, SOPs, and current process information. We aim to minimize the burden on your team while ensuring enough collaboration to make informed decisions and deliver effective outcomes.
Can we engage Instem consultants on an ongoing or part-time basis?
Yes. In addition to defined projects, we offer flexible consulting agreements that provide access to named SMEs for a set number of hours per period. This allows you to retain expert support without investing in full-time internal resources.
How are projects structured and billed?
Contracts can be structured in different ways depending on your needs. Some are delivered on a weekly or monthly basis, while others are agreed as fixed-fee (lump-sum) engagements. We also offer flexible, ongoing contract arrangements that can combine both approaches.
Speak with Our Experts Today
Access to the right expertise at the right time is critical to maintaining continuity, reducing risk, and meeting timelines.
Speak with our experts today to see how Instem Catalyst can extend your team and support your delivery goals.
