Empowering Scientific Breakthroughs Together
Transforming ideas into life-saving medications. Leading the way in drug development services.
We specialize in drug development consulting services, offering comprehensive solutions for biotech and biopharma companies
Lead Discovery: Finding potential drug candidates through high-throughput screening, computational approaches, and rational drug design.
Target Identification: Identifying disease-relevant molecules or pathways.
Target Validation: Confirming targets for drug intervention in collaboration with CROs
Drug Discovery
Lead Optimization: Enhance promising lead candidates by refining potency, selectivity, and key properties like absorption and metabolism.
Preclinical Testing: Evaluate optimized leads in animal models for safety, efficacy, and pharmacological properties, including toxicology, pharmacokinetics, and efficacy studies through trusted CROs or partners.
Proof of Concept: Validate drug candidate feasibility and effectiveness.
Absorption, Distribution, Disposition, Metabolism, & Excretion (ADME): Evaluation of a drug's pharmacokinetic properties.
In Vivo, In Vitro, and Ex Vivo Assay Development: Development of various assays to study drug behavior in different contexts.
Drug Delivery: Optimization of methods to deliver drugs effectively.
Formulation Optimization: Refinement of drug formulations to enhance efficacy and stability.
Bioavailability Optimization: Enhancement of a drug's availability for absorption.
Defining Target Product Profile (TPP): Establishing the desired characteristics and goals for a drug product.
Preclinical Development
Clinical Development
Clinical Trial Design: Designing rigorous and ethically sound clinical trials that meet regulatory standards. From defining study objectives to selecting patient populations and crafting protocols, we ensure scientific robustness throughout.
Regulatory Strategy and Compliance: We help devise regulatory strategies for clinical trial approvals and submissions to agencies like the FDA and EMA.
Protocol Development and Optimization: Our team helps draft and refine clinical trial protocols.
Site Selection and Management: We streamline site selection, negotiation, and management processes, ensuring trials run smoothly from initiation to closeout.
Patient Recruitment and Retention: Our tailored strategies enhance patient enrollment and retention through targeted digital marketing and community engagement initiatives.
Project Management and Oversight: We provide meticulous project management to keep trials on schedule, within budget, and in adherence to rigorous quality standards.
Strategic Partnerships and Alliances: We facilitate strategic partnerships and licensing opportunities to optimize clinical development outcomes, from partner evaluation to technology transfer facilitation.
Process Development: Enhancing manufacturing efficiency, scalability, and regulatory compliance for biopharmaceutical products.
Analytical Development: Expertise in developing and validating analytical methods for product characterization and quality control.
Technology Transfer: Facilitating seamless transfer of manufacturing processes and analytical methods while maintaining regulatory compliance.
Quality Assurance and Control: Implementing robust quality systems to ensure consistent high-quality biopharmaceutical production.
Regulatory Affairs: Guiding successful submissions to regulatory agencies like FDA and EMA, including INDs, BLAs, and other filings.
CMC Strategy: Developing comprehensive strategies aligning chemistry, manufacturing, and controls with regulatory expectations.
Risk Assessment and Mitigation: Identifying and mitigating risks in manufacturing processes and supply chains to ensure product quality and supply continuity.
CMC Due Diligence: Evaluating CMC aspects in partnerships, mergers, acquisitions, or licensing deals to assess risks and opportunities.
Lifecycle Management: Supporting post-approval activities to ensure continued product quality and compliance.
CMC Support
Data Analysis
Data Management and Integration: We develop strategies to manage and integrate diverse datasets crucial to drug development, ensuring quality and accessibility across multiple sources.
Data Analysis and Visualization: Employing advanced statistical analysis, machine learning, and bioinformatics, we extract insights from complex datasets and visualize findings effectively.
Biomarker Discovery: Using genomic, proteomic, and metabolomic data alongside bioinformatics tools, we identify and validate biomarkers crucial for personalized medicine.
Drug Target Identification and Prioritization: Our experts support feasibility and safety assessments for drug targets, facilitating informed decision-making in target selection.
Drug Repurposing and Virtual Screening: We assist in identifying potential drug repurposing candidates and conduct virtual screening of compound libraries using computational methods.
Market Insights
Market Research: Thoroughly researching pharmaceutical and healthcare industry dynamics, trends, and competitors.
Competitive Analysis: Evaluating competitors' strategies, products, and market positions to uncover opportunities and threats.
Market Segmentation: Segmenting markets by demographics, geography, and behavior to target customer groups effectively.
Product Positioning: Strategically positioning products by emphasizing unique features and addressing customer needs.
Market Forecasting: Predicting market trends, demand, and growth using data and analytics.
Regulatory Analysis: Providing insights into regulatory requirements and compliance in the pharmaceutical and healthcare sectors.
Strategic Recommendations: Delivering actionable insights and recommendations to guide informed business decisions.
