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Strategic Product Development & Consulting
Our Approach
With 25 years of legacy, Lambda Therapeutic Research, a trusted full-service CRO, drives innovation in drug development through its Strategic Product Development & Consulting services, led by a dedicated Medical Innovation Group. This specialized team serves as a vital link between cross-functional domains.
Our Strategic Product Development & Consulting services adopt a forward-thinking approach, leveraging deep expertise and strategic insights to advance products through their lifecycle. We conduct comprehensive analyses, including competitor data mining, direct and indirect comparisons, and evidence-based recommendations. Our scope extends to therapeutic positioning, disease epidemiological forecasting, and delivering actionable clinical insights supported by SWOT analyses to optimize clinical development strategies.
The Medical Innovation Group brings together experts in non-clinical, clinical, regulatory, and pharmaceutical disciplines, ensuring robust alignment with international regulatory standards. This dynamic team is committed to excellence in every phase of drug development, providing exceptional support to ensure the success of your programs.
Partner with Lambda and Novum to leverage our expertise and drive the success of your clinical development programs.
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.