Services are delivered with expertise and high quality to ensure reliable results
Pharmaceutical Product Development
In addition to identification of a suitable drug molecule during the discovery phase of drug development, the success of a new chemical entity (NCE) depends on formulating the drug into a dosage form that reaches the patient.
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We provide advice on the following services in the product development area:
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Assessment and recommendation for preformulation activities: physicochemical properties, pka and salt screening, solid state studies, drug-excipient compatibility, and stability studies
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Quality by design (QbD) during the formulation stage: development of target product profile (TPP), identification of critical material attributes (CMA), critical quality attributes (CQA) and critical process parameters (CPP)
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Quality risk management and risk assessment using various tools
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Design space generation using Design of Experiments (DoE)
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Process Analytical Technology (PAT) to understand and control the process
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Assay development and validation (Analytical QbD) for forced degradation studies and stability studies as per ICH guidelines
Health Economics & Outcomes Research
Cost and efficacy are important determinants for the adoption of new interventions relative to a standard(s). Economic analysis from the perspective of patients, payers and healthcare institutes is necessary to support reimbursement strategies and ensure optimal patient outcome.
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We provide the following services in the HEOR area:
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Budget Impact Analysis
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Cost of Illness studies
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Economic model development and validation
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Development and validation of Patient Reported outcome (PROs)
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Data mining from patient registries, electronic health records, patient reported outcome (PRO) measures, etc.
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Retrospective database analysis and design of prospective observational studies
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Systematic Literature Review (SLR) and meta-analysis
Statistical Analysis
We provide in depth statistical analysis services:
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Analysis of clinical study, clinical trial and observational study results using common statistical techniques
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Preparation of statistical analysis reports (SAR)
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Validation of Patient Reported Outcome (PRO) measures
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Meta-analysis for comparison of treatments and interventions
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Sample size analysis for clinical and nonclinical studies
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Statistical Process control charting and calculation of capability indices
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Design of Experiments (DoE) and design space generation
Training
Training and keeping your employees and business leaders current with new and emerging guidelines is of paramount importance in the life sciences and pharmaceutical industry.
We develop customized e-learning or in-house training programs in the following areas:
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Good Manufacturing Practices (GMP) Code of Federal Regulations Title 21, Part 210 and 211, ICH Q7
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Quality by Design (QbD) and Process Analytical Technology (PAT)
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ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8 (R2) and FDA guideline for Process Analytical Technology (PAT)
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Quality Risk Management (QRM) and risk assessment tools
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Process Validation (as per FDA guidance and EMA guidance)
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Training programs can be developed to teach specific statistical techniques for sampling methods and data handling as per manufacturing process used
Writing
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We provide advice on the following services in the area of writing:
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Manuscript preparation for peer-reviewed journals
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Scientific literature reviews
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Poster presentation and slide decks
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Clinical and nonclinical study reports
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Preparation of Chemistry, Materials and Control (CMC) documents for IND applications
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Standard Operating Procedures (SOP) for quality related activities
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Statistical Analysis Reports