Ergomed Consulting: Strategic Expertise to Accelerate your Drug Development and Global Market Entry
Global Regulatory Expertise, Local Market Insight
At Ergomed Consulting, we bring a unique combination of global regulatory affairs consulting and local market insight to accelerate your clinical development. With decades of experience in regulatory strategy for drug development, our team includes former FDA and EMA regulators, key opinion leaders (KOLs), and industry experts.
This diverse regulatory and clinical expertise enables us to guide sponsors through complex international requirements while remaining aligned with evolving regional expectations.
Ergomed Consulting Services Include:
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From early strategic planning to indication prioritization and gap analysis, our experts can help propel early-stage success. Our deep insights into regulatory strategy and clinical development planning, combined with global expertise, streamline your pathway to clinical trials and ensure your clinical development program is robustly positioned for success.
-
Innovative trial designs, such as adaptive, platform, and Bayesian-based approaches, provide powerful tools to maximize clinical insights, enhance efficiency, and reduce risks. Our experts work closely with you to customize your trial design, leveraging advanced methodologies to deliver evidence-driven results that inform strategic decision-making.
-
The most effective regulatory strategy starts early, with thoughtful pre-IND planning. We can help you optimize IND meetings, provide targeted nonclinical regulatory guidance, navigate dynamic global regulatory landscapes. That hands-on guidance continues through market application and regulatory review—preparing submissions, addressing regulator feedback, accelerating the approvals process.
-
Our team of expert drug developers offers deep scientific and multidisciplinary experience spanning academia, investigational sites, sponsors, and regulatory agencies, delivering medical, scientific, and strategic insights you can trust. We provide flexible, tailored support, whether integrating seamlessly with your team through interim placement of key executives such as a CMO or CSO, offering holistic service solutions, or engaging on an as-needed basis. Additionally, we provide specialized support including in-licensing assessments, due diligence activities, and customized training programs to empower your team.
-
You need to ensure robust safety oversight during your clinical trial, enabling rapid, data-driven decisions on trial continuation or termination in response to emerging data. Ergomed Consulting delivers expert DSMB oversight by engaging independent committee members with distinguished credentials—such as key opinion leaders, expert statisticians, and seasoned regulatory experts. Through comprehensive DSMB charters, efficient meeting organization, and timely data review, the DSMB provides unbiased assessments that swiftly evaluate evolving safety signals and safeguard patient safety.
-
Real world data is transforming drug development by bridging the gap between controlled clinical trials and everyday patient outcomes. Our experts harness advanced analytics to unlock the power of big data from diverse sources, combined with novel approaches like external control arm studies, to deliver compelling evidence that accelerates your development timeline and maximizes the value of your drug.
Multidisciplinary Regulatory Expertise to Accelerate Success
Across every phase of the product lifecycle, Ergomed Consulting experts elevate your product viability–from shortened pathways to trial to regulatory agility and compliance, expedited global entry to sustained competitive edge. It’s what we do.
KOLs, Former Regulators, Expert Strategists
12+ Areas of Expertise Backed by Decades of Experience
Complex Diseases and Novel Therapies
End-to-End Drug Development Advisory
Flexible Model and Bespoke Service
Global Perspective Combined with Local Insight
Ergomed Consulting Solutions
Ergomed Consulting delivers expert, customized regulatory consulting for clinical trials across the entire drug development lifecycle—from discovery and preclinical planning to regulatory submission and post-market management. With deep therapeutic knowledge, former regulators, and cross-functional CRO integration, we equip sponsors with the insight and support needed to move forward—confidently and compliantly—at every milestone.
Discovery & Preclinical Phase
In the early stages of drug development, companies often face significant challenges such as funding gaps, complex regulatory landscapes, and translational hurdles that can delay progress.
Clinical Research (Phases I–III)
Clinical development is often complicated by complex protocols, regulatory barriers, and fragmented market access strategies.
Market Application & Regulatory Review
During the market application and regulatory review phase, companies must navigate a complex regulatory framework, minimize the risk of submission delays, as well as disparate review and approval process.
Post-Market Safety & Lifecycle Management
Following market approval, evolving safety expectations, increasing demands for evidence generation, and lifecycle competition present ongoing challenges.
Strategic Pre-IND Consulting for Gene Therapy in Rare Leukemia
Our latest case study showcases how Ergomed Consulting guided a biotech innovator through the complexities of early development for a gene therapy targeting a rare form of leukemia.
Early Stage Development in Rare Pediatric Oncology
Our latest case study highlights how Ergomed Consulting supported a biotech company developing a novel therapy for a rare pediatric cancer—navigating the complexities of early-phase clinical development in an ultra-orphan indication.
Market Approval for a Novel Non-Hodgkin Lymphoma (NHL) Therapy
Our latest case study reveals how Ergomed Consulting partnered with a pharmaceutical company to successfully navigate the final stretch of drug development—securing market approval for a novel treatment in a competitive Non-Hodgkin Lymphoma (NHL) landscape.
Post-Market Safety & Risk Management in Duchenne Muscular Dystrophy (DMD)
Our latest case study highlights how Ergomed Consulting supported a pharmaceutical company specializing in rare neurological diseases to manage long-term safety and sustain market performance for a therapy treating Duchenne Muscular Dystrophy (DMD).
Team Member Spotlight:
Nan Shao, Executive Vice President of Ergomed Consulting
Our Executive Vice President of Ergomed Consulting, Nan Shao, brings over two decades of strategic and operational leadership in drug development. With a strong foundation as a trained statistician and extensive experience in both pharmaceutical and CRO settings, Nan has successfully led initiatives spanning the entire drug development lifecycle across diverse therapeutic areas.
Her expertise encompasses scientific rigor and operational excellence, empowering stakeholders through strategic use of data, optimized trial strategies, and patient-centric innovations. Nan is recognized for building collaborative, consultative partnerships that drive meaningful outcomes for clients and advance patient care.
In her role, Nan continues to shape the strategic direction of Ergomed Consulting by integrating data-driven insights, scientific innovation, and a steadfast commitment to improving healthcare outcomes.
Navigate the Complexities of the Entire Drug Development Path with Ergomed Consulting
At Ergomed Consulting, we simplify the complex with trusted regulatory consulting for clinical trials that spans the entire drug development lifecycle. From early-stage planning to regulatory approval and post-market safety, our multidisciplinary team delivers integrated medical, scientific, statistical, and regulatory guidance tailored to your asset.
Whether you’re advancing a first-in-class therapy or refining a late-stage asset, our global regulatory affairs consulting helps you reduce risk, accelerate timelines, and bring safe, effective therapies to patients—worldwide.
Unparalleled Expertise,
Ergo, Flawless Execution
Contact Us
Our Complementary Services
See how Ergomed can support your clinical trial.
More Ergomed Services
Find out how Ergomed supports your clinical trial objectives.
Discover Our Latest Insights
Access Ergomed's resources for the latest in clinical trial trends and innovations.
-
-
Case Studies
Strategic Pre-IND Consulting for Gene Therapy in Rare Leukemia
Learn More
-
-
Case Studies
Early Stage Development in Rare Pediatric Oncology
Learn More
-
-
Case Studies
Market Approval for a Novel Non-Hodgkin Lymphoma (NHL) Therapy
Learn More
-
-
Case Studies
Post-Market Safety & Risk Management in DMD
Learn More
Ergomed Consulting Services Include:
-
From early strategic planning to indication prioritization and gap analysis, our experts can help propel early-stage success. Our deep insights into regulatory strategy and clinical development planning, combined with global expertise, streamline your pathway to clinical trials and ensure your clinical development program is robustly positioned for success.
-
Innovative trial designs, such as adaptive, platform, and Bayesian-based approaches, provide powerful tools to maximize clinical insights, enhance efficiency, and reduce risks. Our experts work closely with you to customize your trial design, leveraging advanced methodologies to deliver evidence-driven results that inform strategic decision-making.
-
The most effective regulatory strategy starts early, with thoughtful pre-IND planning. We can help you optimize IND meetings, provide targeted nonclinical regulatory guidance, navigate dynamic global regulatory landscapes. That hands-on guidance continues through market application and regulatory review—preparing submissions, addressing regulator feedback, accelerating the approvals process.
-
Our team of expert drug developers offers deep scientific and multidisciplinary experience spanning academia, investigational sites, sponsors, and regulatory agencies, delivering medical, scientific, and strategic insights you can trust. We provide flexible, tailored support, whether integrating seamlessly with your team through interim placement of key executives such as a CMO or CSO, offering holistic service solutions, or engaging on an as-needed basis. Additionally, we provide specialized support including in-licensing assessments, due diligence activities, and customized training programs to empower your team.
-
You need to ensure robust safety oversight during your clinical trial, enabling rapid, data-driven decisions on trial continuation or termination in response to emerging data. Ergomed Consulting delivers expert DSMB oversight by engaging independent committee members with distinguished credentials—such as key opinion leaders, expert statisticians, and seasoned regulatory experts. Through comprehensive DSMB charters, efficient meeting organization, and timely data review, the DSMB provides unbiased assessments that swiftly evaluate evolving safety signals and safeguard patient safety.
-
Real world data is transforming drug development by bridging the gap between controlled clinical trials and everyday patient outcomes. Our experts harness advanced analytics to unlock the power of big data from diverse sources, combined with novel approaches like external control arm studies, to deliver compelling evidence that accelerates your development timeline and maximizes the value of your drug.
Multidisciplinary Regulatory Expertise to Accelerate Success
Across every phase of the product lifecycle, Ergomed Consulting experts elevate your product viability–from shortened pathways to trial to regulatory agility and compliance, expedited global entry to sustained competitive edge. It’s what we do.
Ergomed Consulting Solutions
Ergomed Consulting delivers expert, customized regulatory consulting for clinical trials across the entire drug development lifecycle—from discovery and preclinical planning to regulatory submission and post-market management. With deep therapeutic knowledge, former regulators, and cross-functional CRO integration, we equip sponsors with the insight and support needed to move forward—confidently and compliantly—at every milestone.
Discovery & Preclinical Phase
In the early stages of drug development, companies often face significant challenges such as funding gaps, complex regulatory landscapes, and translational hurdles that can delay progress.
Clinical Research (Phases I–III)
Clinical development is often complicated by complex protocols, regulatory barriers, and fragmented market access strategies.
Market Application & Regulatory Review
During the market application and regulatory review phase, companies must navigate a complex regulatory framework, minimize the risk of submission delays, as well as disparate review and approval process.
Post-Market Safety & Lifecycle Management
Following market approval, evolving safety expectations, increasing demands for evidence generation, and lifecycle competition present ongoing challenges.
Strategic Pre-IND Consulting for Gene Therapy in Rare Leukemia
Our latest case study showcases how Ergomed Consulting guided a biotech innovator through the complexities of early development for a gene therapy targeting a rare form of leukemia.
Early Stage Development in Rare Pediatric Oncology
Our latest case study highlights how Ergomed Consulting supported a biotech company developing a novel therapy for a rare pediatric cancer—navigating the complexities of early-phase clinical development in an ultra-orphan indication.
Market Approval for a Novel Non-Hodgkin Lymphoma (NHL) Therapy
Our latest case study reveals how Ergomed Consulting partnered with a pharmaceutical company to successfully navigate the final stretch of drug development—securing market approval for a novel treatment in a competitive Non-Hodgkin Lymphoma (NHL) landscape.
Post-Market Safety & Risk Management in Duchenne Muscular Dystrophy (DMD)
Our latest case study highlights how Ergomed Consulting supported a pharmaceutical company specializing in rare neurological diseases to manage long-term safety and sustain market performance for a therapy treating Duchenne Muscular Dystrophy (DMD).
Team Member Spotlight:
Nan Shao, Executive Vice President of Ergomed Consulting
Our Executive Vice President of Ergomed Consulting, Nan Shao, brings over two decades of strategic and operational leadership in drug development. With a strong foundation as a trained statistician and extensive experience in both pharmaceutical and CRO settings, Nan has successfully led initiatives spanning the entire drug development lifecycle across diverse therapeutic areas.
Her expertise encompasses scientific rigor and operational excellence, empowering stakeholders through strategic use of data, optimized trial strategies, and patient-centric innovations. Nan is recognized for building collaborative, consultative partnerships that drive meaningful outcomes for clients and advance patient care.
In her role, Nan continues to shape the strategic direction of Ergomed Consulting by integrating data-driven insights, scientific innovation, and a steadfast commitment to improving healthcare outcomes.
Navigate the Complexities of the Entire Drug Development Path with Ergomed Consulting
At Ergomed Consulting, we simplify the complex with trusted regulatory consulting for clinical trials that spans the entire drug development lifecycle. From early-stage planning to regulatory approval and post-market safety, our multidisciplinary team delivers integrated medical, scientific, statistical, and regulatory guidance tailored to your asset.
Whether you’re advancing a first-in-class therapy or refining a late-stage asset, our global regulatory affairs consulting helps you reduce risk, accelerate timelines, and bring safe, effective therapies to patients—worldwide.
Unparalleled Expertise,
Ergo, Flawless Execution
Our Complementary Services
See how Ergomed can support your clinical trial.
More Ergomed Services
Find out how Ergomed supports your clinical trial objectives.
Discover Our Latest Insights
Access Ergomed's resources for the latest in clinical trial trends and innovations.
-
- Case Studies
Strategic Pre-IND Consulting for Gene Therapy in Rare Leukemia
Learn More -
- Case Studies
Early Stage Development in Rare Pediatric Oncology
Learn More -
- Case Studies
Market Approval for a Novel Non-Hodgkin Lymphoma (NHL) Therapy
Learn More -
- Case Studies
Post-Market Safety & Risk Management in DMD
Learn More