Solutions

Clinical & Product Development

The clinical development landscape is becoming increasingly complex. 

Clinical manufacturing requires scientific and technical attention to detail, keen understanding of program needs, proactive identification and mitigation of potential gaps. At Verista, our consultants have had extensive and diverse experiences in clinical and product development. Our capabilities include process and analytical development, scale up, technical transfers of methods and manufacturing processes, trial data management, application selection & implementation support, quality & compliance assessments, and audits.

Chemistry, Manufacturing & Control

Chemistry, Manufacturing Controls (CMC) has become a critical bridge between development and commercial. Verista provides technical leadership that can facilitate your document review, filing preparations, and technical SME needs. Our colleagues work in collaborative partnerships with your leadership and development SME and CMC teams.

Manufacturing automation and validation are areas that require expertise and experience for success. Our seasoned advisors can help you with all these aspects of manufacturing, including vision inspection, fill and finish and packaging needs.

Quality and CMC Regulatory SMEs leverage their experiences and provide guidance in all phases of drug development life cycle.

CMC Strategy and Program Leadership

Manufacturing Automation and Validation

CMO and Vendor Audits, Assessments and Remediations

Product Development SMEs

Our team can assist your development professional by providing CMC technical and strategic advisory, CDMO and vendor management & support, manufacturing and method technology transfer and scale up of your product in early to late-stage development. Our experienced and hands on technical experts leverage their expertise in the biopharmaceutical industry to provide comprehensive technical and strategic solutions.

CMC advisory spanning early to late-stage process and method development

CMO and vendor management and support

Technical SMEs across several disciplines in product development

Experienced, hands on experts in the areas of clinical and product development will leverage years of technical and strategic expertise in the biopharmaceutical industry to create comprehensive solutions for your programs.

Clinical Development Support

The clinical operations landscape is increasingly challenging as the industry manages complex clinical trials, recruitment, supply chain, remote patient studies and patient data via devices. Clinical trials require significant data and process integrity. Navigating the application landscape requires deep understanding of business requirements and rigor in implementation. Experienced in many areas across clinical development, our team will work side by side with on data review and associated filings to ensure the efficient execution of your clinical programs.

Clinical trial data management

Application selection and implementation support

Quality and compliance assessment /audit for your clinical trials