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Strategic Product Development & Consulting
Our Approach
At Lambda Therapeutic Research, our Strategic Product Development & Consulting service is driven by a dedicated Medical Innovation Group, acting as a vital link between cross-functional domains and our global clinical drug development subsidiaries.
Our Strategic Product Development & Consulting service encompasses a forward-thinking approach to drive innovation in drug development, leveraging in-depth expertise and strategic insights to propel your products successfully through their lifecycle. We engage in comprehensive analysis that includes competitor data mining & analysis, direct and indirect comparisons, and the application of evidence-based recommendations. Our approach extends to therapeutic positioning and disease epidemiological forecasts. The insights we glean are presented succinctly, accompanied by a SWOT analysis, and culminate in valuable clinical insights, potentially optimizing clinical development facets.
Our Medical Innovation Group comprises experts from non-clinical, clinical, regulatory, and pharmaceutical domains, further reinforcing our commitment to international regulatory bodies. This dynamic team excels in a wide spectrum of activities that are vital to the success of your drug development journey.
Our Approach
At Lambda Therapeutic Research, our Strategic Product Development & Consulting service is driven by a dedicated Medical Innovation Group, acting as a vital link between cross-functional domains and our global clinical drug development subsidiaries.
Our Strategic Product Development & Consulting service encompasses a forward-thinking approach to drive innovation in drug development, leveraging in-depth expertise and strategic insights to propel your products successfully through their lifecycle. We engage in comprehensive analysis that includes competitor data mining & analysis, direct and indirect comparisons, and the application of evidence-based recommendations. Our approach extends to therapeutic positioning and disease epidemiological forecasts. The insights we glean are presented succinctly, accompanied by a SWOT analysis, and culminate in valuable clinical insights, potentially optimizing clinical development facets.
Our Medical Innovation Group comprises experts from non-clinical, clinical, regulatory, and pharmaceutical domains, further reinforcing our commitment to international regulatory bodies. This dynamic team excels in a wide spectrum of activities that are vital to the success of your drug development journey.
Innovative Conceptualization
Employing pharmaceutical intelligence and applied pharmacology concepts for existing and novel drug development programs, fostering innovative thinking.
Unmet Needs Identification
Identifying significant unmet needs across therapeutic areas and proposing solutions to bridge these gaps.
Key Opinion Leader (KOL) Engagement
Establishing strong connections with national and international KOLs and forming an Advisory Board to guide and enrich projects.
Global Trends Mapping
Comprehensive analysis of global trends through competitive landscape assessment, market research, SWOT analysis, and a profound understanding of regulatory frameworks to craft detailed innovative proposals and roadmaps for drug/dosage form development (Phase II/III).
Regulatory Support
Preparation and review of Scientific Advice Briefing packages for global regulatory authorities, addressing project-specific clinical queries from regulatory authorities, and offering regulatory roadmap building for special programs under PUMA, BPCA, PREA, etc.
Strategic Consulting
Offering consulting services for clinical development program strategies, ensuring compliance with targeted regulatory submissions in a cost-effective and timely manner.
Therapeutic Positioning Expertise
Advising on the optimal therapeutic positioning of a product throughout the development and registration process.
Holistic Approach
Providing an evidence-based holistic approach to cater to modern healthcare needs, in consultation with sponsor’s medical and scientific experts through consensus building.
Training and Knowledge Dissemination
Imparting training to staff across various departments in Medical, Clinical Pharmacology, and Principles of Therapeutics. Additionally, preparing informative blog/display materials for websites.
Data Utilization and Optimization
Providing advice on pre-clinical data packages, toxicology data, PK characterization, modeling, meta-analysis, data management, and the use of principles of extrapolation for seeking regulatory waivers.
Let's Unveil New Therapies Together
Connect with our experts to leverage our proven track record of clinical research excellence.