Program Management & Regulatory Submissions

Projects can enter SwRI’s pharmaceutical development pipeline at various stages of maturity. Our seasoned staff will quickly assess and determine gaps or high risk points for Chemistry Manufacturing and Control (CMC) and regulatory strategy in order to best advise our client.

Since 2004, our project managers have direct experience advancing drugs from concept through Food and Drug Administration (FDA) licensure. Our project managers have direct experience setting up type 2 FDA meetings, preparing meeting packages, and identifying strategic questions that could impact development and lifecycle management costs. We have experience developing nonclinical safety and efficacy studies that will answer key development questions and expedite FDA review. We have experience writing, hyperlinking, and submitting investigational new drugs (INDs) in electronic Common Technical Document (eCTD) format and submitting IND updates, even through phase 3 clinical studies.

Once under agreement, project managers at SwRI are completely empowered to execute the project. The SwRI project manager will select specific staff with appropriate skills and authorize purchases; providing highly effective and efficient project teams to address the client’s requirements. The SwRI project manager has access to a full collection of robust enterprise-wide tools.

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SwRI’s project managers understand that communication with our clients is critical. As such, the project manager will conduct frequent project updates with involved staff and contractors and provide reports to our clients describing progress, near-term issues, and performance against budget. Potential disruptions to the project schedule are discussed with the project team, and then forwarded to our clients with recommendations for resolution.

Cost and schedule are tracked and reported to the client to ensure the viability of the program and to provide all required deliverables within the limits of the contract. SwRI uses real-time accounting methods to track project budgets and project deliverables. We also use earned value management systems (EVMS) as part of our project management strategy. Using EVMS, the impact of minor changes in schedule can be quantified in real time so that the budget impact – not only on the program element, but on the entire program – can be known in real time. Thus, budget risk and schedule risk are known when decisions are made. Using this system, the threshold of deviation can be agreed to with the client at the onset of the program so that everyone has the same level of certainty regarding the progress of the program.

SwRI also uses online deliverables tracking internally and for its subcontractors to help manage on-time performance. Our multi-functional, integrated systems for project management result in project goals that are routinely met with minimum risk.

SwRI is an FDA-registered drug establishment (1614272) that supplies pharmaceuticals and drug products made under current Good Manufacturing Practices (cGMP) requirements. SwRI personnel can anticipate IND application requirements for all aspects of pharmaceutical development, so (where appropriate) data will be collected in anticipation of key elements and formats required for regulatory submission.

For more information on how SwRI can help with your program management and regulatory submission needs, contact Darrel Johnston.

Benefiting government, industry and the public through innovative science and technology
Southwest Research Institute® (SwRI®), headquartered in San Antonio, Texas, is a multidisciplinary, independent, nonprofit, applied engineering and physical sciences research and development organization with 10 technical divisions.
03/11/16