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DRUG DISCOVERY & DEVELOPMENT

Drug Discovery & Development Services

 

Technology Assessments

 

Business Development

 

Project Management

 

Licensing & Partnering Opportunities

 

R&D, Prototyping, Pilot Plants & EPC Sourcing

 

Supply Chain Recommendations

 

Operations Management

 

R&D, Engineering & Product Development Roadmaps

DRUG DISCOVERY & DEVELOPMENT FOCUS

Discovery & Validation

 

 

 

 

High Throughput Screening

 

  • Combinatorial Chemistry

  • Genomic, Proteomic, Glycomic, Tissues & Cell Assays

  • SNP/Mutation Analysis

  • Sequencing

 

 

Informatics

 

  • Bioinformatics

  • Cheminformatics

  • Structure based design

  • Lab Informatics (LIMS), Electronic Notebooks (ELN)

  • Text, Image, Scientific (e.g. chemical structures, biological) search and workflows

 

Identification & Validation of Disease Models and Mechanism of Action

 

 

Preclinical/Phase O

 

  • PK/PD

  • Toxicity

  • Initial safety studies

  • Animal models/results

  • Imaging studies

 

 

Reagents Development

 

 

  • Antibodies

  • Nucleic Acids

  • Peptides/Fragments

  • Signal amplification probes

  • Tissues

  • Biomarkers

 

 

 

 

 

Clinical Development

 

 

 

 

Phase 1- 4 Clinical Trials

 

  • Small molecules, Biologics

  • Trial Design & Selection of statistically significant end points

  • Safety, Efficacy, Risk-Benefit analysis

  • Recruitment

  • Analytical testing

  • Data Collection & Analysis

  • Adverse events

  • Post marketing surveillance/long term studies

 

 

Informatics

 

  • Electronic Data Capture (EDC), CRF, Regulatory submissions

  • Database Design, Integration, Reporting

  • Biostatistics

  • Data Analytics & Trial Insights, including advanced visualization tools

 

 

Chemistry, Manufacturing & Controls

 

  • Quality by Design techniques (QbD)

  • Process Analytical Technologies (PAT)

  • API development, variability analysis

  • Formulations

  • Stability/Release analysis

  • Complex Biologics Processes- e.g. Cell Lines, High volume fermentation systems

  • Risk analysis

 

 

Companion Biomarker-Drug Development

 

  • Linking in-vivo or in-vitro biomarkers with pharmaceutical or biotech drugs for personalized therapy applications and minimizing side effects

  • Co-development trial design and analysis (drug and diagnostic product)

 

 

Generics

 

 

  • Dosing

  • Bioequivalence studies

  • Safety analysis & adverse events

 

Regulations & Evidence based Outcomes

 

 

Regulatory

 

  • IND

  • NDA

  • ANDA

  • BLA

  • cGMP

  • Marketing/Labeling

  • International audits of supply chain & global manufacturing facilities


Evidence based Medicine/Health Outcomes

 

  • QALY

  • Drug comparision and effectiveness analysis

  • Registries, Database review & analysis

 

 

 

 

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