INDiGO-Select & INDiGO®

INDiGO®is a vertically-integrated and complete clinical-enabling platform to bring a small molecule from candidate nomination into clinical development. Our unique R&D site in Verona, Italy (formerly a Glaxo-Smith Kline Center of Excellence) co-locates CMC manufacturing and nonclinical development, providing a unique opportunity to fully integrate all aspects of drug development.

For years, drug developers have faced the challenge of navigating fragmented workflows, siloed expertise, and inefficient vendor coordination, all while racing against time and budget constraints. Traditional multi-vendor models often lead to delays, time-consuming oversight, scope creep, and an increased risk of missing key deliverables and therefore demanding significant internal resources just to stay on track.

At Evotec, we believe, and proved, that there is a better way.

Evotec is the only service provider offering truly vertically-integrated drug development. At our site in Verona, Italy, the INDiGO platform delivers its full potential - providing a seamless, end-to-end solution that brings together all critical functions - API, Drug Product, Safety, ADME, Regulatory, and Clinical - under one roof. This unique integration enables faster timelines, reduced risk, and greater cost efficiency, setting a new standard for Phase 1 development.

INDiGO is more than an integrated platform, it is a mindset to a holistic development. Our Scientific Project Leaders and multidisciplinary teams view each program as a continuum, aligning scientific goals across phases and anticipating future needs. Whether through full-scope IND-enabling development or modular, milestone-driven plans, INDiGO adapts to our clients’ strategy, funding, and timeline.

With INDiGO-Select, we ensure high-quality candidate selection and de-risk early development. And with our governance model, we offer the strategic scientific oversight and operational flexibility needed to respond to data-driven challenges and evolving program goals.

Evotec combines the strategic depth of a large pharma with the agility of a CRO—delivering integrated, patient-focused drug development that’s built for success.

Our INDiGO-Select platform provides a unique, flexible, and efficient approach to de-risk your identified clinical candidate, addressing the most common causes of delay and failures.  Applied towards a single molecule or a short list of candidates, this integrated package will address any remaining liabilities in terms of developability and safety that the discovery program may not have included so far. We will fully de-risk your molecule candidate to ensure its “readiness” for development before investing millions of dollars and months of cash burn in clinical-enabling studies. In practice, this approach has reduced the fail rate of clinical candidates from 30-40% to 7%.¹

INDiGO-Select is a tiered approach that can be applied to a single molecule or a subset of potential candidates. The platform can be used either before entrance to INDiGO, or it can be imbedded into an INDIGO program. Our scientists will employ our data-driven approach, utilizing any data already available, to create a molecule-specific plan at proposal stage.  Within this plan, your compound (or compounds) will be assessed with a particular focus on: 

• Manufacturing scalability
• Solid state characterization
• Early formulation assessment
• in-vitro and in-vivo safety
• DMPK

We can also help with a broader derisking strategy where development of PK/PD and biomarkers as well as biology support are included.

Armed with the data package generated by INDiGO-Select, you will be provided with the information you need to nominate your clinical candidate with confidence.

_{1 Duxin N, Gao W, Hu H, Zhou S. 2022. Why 90% of clinical drug development fails and how to improve it? Acta Pharmaceutica Sinica B 2022;12(7):3049-3062}

At our unique site in Verona, Italy, INDiGO brings together all critical disciplines under one roof. This vertical integration eliminates the inefficiencies and delays often associated with coordinating multiple vendors. Our comprehensive platform includes everything from cGMP manufacturing and GLP safety assessments to regulatory consultancy and clinical trial management. The result? A streamlined, cohesive approach that accelerates your program's path to the clinic.

Scientific Project Leader: Driving Strategy, Integration, and Success

At the heart of every INDiGO program is a Scientific Project Leader (SPL), a drug development expert who ensures your program is guided by a data-driven, agile, and strategically aligned plan from start to IND submission.

The SPL is responsible for:

• Defining and executing a holistic development strategy, tailored to your molecule and aligned with regulatory and clinical goals
• Serving as your primary technical and operational point of contact, ensuring seamless communication and scientific continuity
• Leading a multidisciplinary team across CMC, preclinical, and regulatory domains; with a strong focus on cross-functional integration and agility
• Anticipating project threats as well as opportunities through proactive scenario planning and adapting plans to maintain momentum and scientific integrity

Working in tandem with a dedicated Project Manager, who oversees timelines and budget, the SPL ensures that your program remains on track, on budget, and fully aligned with your expectations.

This dual-leadership governance model, unique to Evotec, combines strategic scientific oversight with operational excellence. It enables:

• Transparent and efficient decision-making
• Streamlined execution across all disciplines
• Accelerated timelines without compromising quality
• A single, integrated team mindset that views development as a continuum

By embedding this level of leadership and integration into every INDiGO program, Evotec delivers a robust, flexible, and cost-effective development engine, one that consistently outperforms traditional, fragmented approaches.

Having completed more than 87 INDiGO programs successfully, we have proven experience that we apply to every program to ensure on time in full delivery. With a focus on quality, we have successfully delivered clinical candidates within a wide variety of therapeutic areas ranging from CNS disorders to oncology and metabolic diseases.

We have demonstrated success with complex chemistry (from 3-15 steps), while supporting animal studies across non-rodent and rodent species.

Our drug product formulation and manufacturing team has successfully developed challenging oral clinical formulations including poorly water soluble compounds that require bio-enhancement strategies (including Spray-Dry Dispersion, Hot Melt Extrusion, etc.

Our INDiGO projects can be delivered in less than 52 weeks with a customized project strategy designed to address your expectations for time, cost, candidate properties, and quality. Additionally, our unique integration model allows us to maintain flexibility in critical path activity scheduling, allowing us to reduce delays related to unexpected results throughout the clinical-enabling process.

Find out how Evotec can accelerate your candidate to clinical development and improve your probability of success - Contact us to discuss.

• Accelerated Development, All Under One Roof
  Fully integrated CMC, preclinical and regulatory capabilities co-located at a single site, enabling seamless coordination, faster execution, and reduced risk.
• Industry-Leading Timelines
  From candidate selection to regulatory submission in typically less than 52 weeks, thanks to optimized workflows and expert-driven planning.
• Strategic Leadership and Expert Governance
  Every program is led by a Scientific Project Leader (SPL) and Project Manager, combining consultant-level scientific insight with operational excellence to drive strategy, execution, and communication.
• Flexible, Custom-Built Development Plans
  Tailored to molecule and goals, with built-in agility to adapt to evolving data, scientific challenges, or funding constraints—without compromising speed or quality.
• Cross-Functional Agility
  Integrated teams across CMC and preclinical disciplines collaborate in real time to adjust scope and maintain momentum, ensuring on-time delivery.
• Excellence in Governance and Risk Management
  Transparent performance tracking, proactive issue resolution, and a robust escalation framework ensure confidence and control throughout development.
• Advanced Technology Platforms and Global Regulatory Expertise
  Cutting-edge tools and infrastructure across all disciplines, with early and continuous engagement from our regulatory team to author, compile, and submit dossiers worldwide via Evotec’s own electronic gateway.
• Embedded Phase 1 Clinical Execution
  INDiGO uniquely integrates Phase 1 clinical studies into the development plan, offering the fastest and most cost-effective path to First-in-Human trials.

INDiGO is not only about speed and efficiency but also about financial prudence. Our integrated approach reduces any scope duplications, coordination costs and eliminates penalties for common development delays. Furthermore, we offer flexible program structures - whether fragmented or segmented—allowing you to tailor your development strategy to align perfectly with your business objectives and resource availability.

Discover how INDiGO can bring unmatched value to your project. Click through to the next chapter to learn more about the innovative solutions and opportunities that await with Evotec. Your pathway to efficient, cost-effective drug development starts here.