PgMO Services Leading to Success
Welcome and thanks for your interest in 6Hats Program Management, inc. Some things that make us special at 6Hats:
Vision to Design with the End in Mind and Skilled to Build the Way.
We’re passionate about protecting health, applying knowledge,
and fusing science with compliance to drive performance that’s
right-first-time, cost-effective, and resource-efficient.
We’re your Program Management talent for early startups, expanding to full-time Program Management Office for later startups and commercial-ready operations.
BioPharma Program Management
Need to formalize early project plans?
Need to scenario-model?
Need multiple projects integrated together with teams internal and external, and with the cash runway, and against risks?
- 6Hats PM will architect and oversee right-sized projects and programs with formal reports for your Board, your teams, your investors.
- And, we can wear additional hats to answer more needs.
- With 6Hats PM already onboard, we’ll minimize timeline slippage while we solve a broad range of challenges.
Alliance, Relationship Management
Need to expand your third party network?
Need technical and/ or quality audits of your network partners
Need to improve vendor performance?
- We’ll evaluate prospective partners – contract development and manufacturing orgs (CDMOs); contract research orgs (CROs); contract labs; supply chain; and, logistics, etc.
- We’ll negotiate new and/ or expanded contracts.
- We’ll performance manage the network of vendors and partners.
Knowledge & Risk Management
Need your data brought together from multiple sources — and efficiently?
Need to manage different levels of access in your SharePoint, Egnyte, or similar digital library?
Have a grip on your risks?
- We’ll architect your data flows for common exploit and certainty in decision making.
- We’ll design and deploy the knowledge management tools with consistent yet custom controls on content and collaborators.
- We’ll facilitate risk exercises, author risk reports, and maintain a risk register.
Virtual Operations Leadership
Need to setup company email, domain, user accounts, and hardware?
Need a new website, social media launched?
Need help creating to maintaining pitch decks and reports for investors and your Board?
- 6Hats PM can support your virtual operations with employee accounts and computer management, cybersecurity, networking and collaborative software tools/ license management.
- We’ll help create, maintain, and communicate slide decks and reports for your Board and investors.
- 6Hats PM can help you create and maintain a new website and LinkedIn launch.
- We’ll identify and establish the tools you need to operate successfully and swiftly.
BioPharma Technology Assessment
Need to scale up or scale out manufacturing process?
Need to assess new manufacturing technology?
Need to risk assess your process?
Need to plan your process validation strategy?
- We can network you with equipment manufacturers, and with others in our industry already using the equipment.
- 6Hats PM has deep experience in sterile filling and cell-based processes and therapies and sterile filling. We can evaluate and advise your process robustness and lead process risk assessments, oversee improvements, and assure validation success.
- We’ll advise comparisons of biopharma manufacturing technologies, from both manufacturing and quality perspectives, plus calculate your ROI (return on investment) with total cost of ownership.
BioPharma Quality Leadership
Need to solve product or process nonconformances, maybe a first-time Out of Specification result?
Need to document changes in process and product, maybe for Tech Transfer?
Need help selecting, auditing, managing a CRO for early studies?
- We will respond to unplanned events efficiently and effectively in ways that assure the developing quality of your product and process.
- 6Hats PM will proactively architect a right-sized quality systems foundation of policies, procedures, etc.
- And, we can lead the establishment of phase-appropriate change management and reliable documentation for ongoing regulatory submissions.
- When evaluating new partnerships, 6Hats PM can support technical and quality audits.
6Hats Program Management links with the entire pharmaceutical value chain
among all levels of your organization internally, and externally across CDMOs, CROs, VCs, and more.