CDMO identification & evaluation

Oversee phase appropriate analytical method development and validation

Drafting phase appropriate analytical method validation protocols & reports

Designing appropriate preformulation studies to enable right formulation development strategies

Selection of container closure system

Guide phase appropriate development and optimization  of Formulation and manufacturing process

Solutions for improving stability or bioavailability

QbD based product development

Scale up strategies for late stage formulation development

Review of pharmaceutical development reports, protocols and batch records

Provide risk mitigation strategies for bioavailability/bioequivalence and labeling

Sourcing of RLD from USA/EU

Suggest appropriate strategies for reverse engineering of RLD

Identify and review patent non-infringing formulation strategies

Guide formulation and process development, and optimization

Help in development of discriminatory and biorelevant dissolution test methods

Recommend strategies for scale up and help solving complex scale up problems

Oversee analytical method validations, protocols and reports

Help in sourcing of impurities/degradants

Help in identification of unknown impurities/degradants

Recommend risk assessment and mitigation strategies 

Help in identification of CROs for conducting bioequivalence studies

Review of bioequivalence study protocols for pilot and pivotal bioequivalance studies

Bioequivalance study monitoring services

Capability/Capacity assessments of CDMOs 

Assessment of product dossiers for in-licensing 

Facility assessment for mergers and acquisitions