We help create the essential documents for your study.

ISF Binders – Pharmacy Binders – Regulatory Binders
Mini Protocols – Patient ID cards – Study Manuals
Leaflets & Brochures – Patient Diaries

We also have global regulatory submission expertise including coordination of wet ink signatures.

The BlueWater Group, Inc. helps Organizations LAUNCH, GROW and SUCCEED by providing Strategic Planning, Manufacturing, Quality Management, Engineering, Supply Chain Management, Auditing and Training Services.

Er Ralston brings over thirty years of experience in numerous business improvement interventions. He is an accomplished coach, trainer, and advisor, specializing in operational excellence and planning to facilitate growth and profitability.

Life Sciences Operations, Supply Chain, Manufacturing, Outsourcing Consulting Services.

Since 2009 we have been helping the scientific community identify and implement the most innovative and sustainable products for their facilities, through a pre-qualified portfolio of premier and specialized manufacturing companies.

Consultant with 30+ years of experience in biopharmaceutical facility design and validation; clinical and commercial manufacturing; quality systems; regulatory submissions and agency inspections.

Successful Pharma & Biotech Executive with financial and operational experience (CEO and CFO positions with both public and private companies) and a solid transactional track record (Capital Market, M&A, BD)
• 35-year Life Sciences experience (Big Pharma - Biotech – Start-up - CRO - CMO) with international assignments (US, Europe, Japan, Africa), conjugating industry knowledge, strategic acumen and deep technical expertise:
 Finance – Strategic Planning – Business Development - M&A - IT
 Capital Raise transactions (public & private) – Investor Relations (US, Europe, Japan) – SEC reporting
 Drug Development - Product Launch & Life Cycle - IP Management
• Solid Corporate Governance practice with 13 years as Corporate Officer for US public companies.
• In-depth knowledge of US Capital Markets, large connection network and solid credibility with Wall Street (Equity, Debt & Convertible Financing with Institutional Investors, PE, VC, IB)
• True Business Partner, data-driven with entrepreneurial, leadership skills and operational focus.

What I do: I help CEOs and business owners get what they want from their businesses without the stress and drama by providing a complete system with simple tools that help your senior leadership team do three powerful things that I call … “VISION-TRACTION-HEALTHY”.

By VISION, I mean getting your leadership team all on the same page with where you’re going, and how you’ll get there.

By TRACTION, I mean getting everyone in the organization to execute with more discipline and accountability toward your Vision.

By HEALTHY, I mean getting your Leadership Team to become a healthy, functional and cohesive team. (Because often they’re not … sometimes strong leaders don’t work well together).

And as goes your leadership team so goes the rest of your company … You get to the point to where everyone in the organization is crystal clear on your vision, executing with discipline and accountability on your vision and consistently gaining traction and advancing as a healthy, fun-loving, functioning cohesive team.

Why it works: All the great books that I’ve read (including The 7 Habits of Highly Effective People, The E-Myth Revisited, Good to Great, Rockefeller Habits, The Goal, etc.) all come together in the book, Traction®.

If any of this resonates with you, I’d love to schedule a FREE 90 Minute Workshop to show you have to use EOS to experience Vision, Traction, and Healthy with your team.

Here’s my GUARANTEE … “If you don’t feel like you get value from our time together, then you don’t pay me” … straight forward, and simple.

Pharmaceutical Physicians providing strategic product development, safety, and medical affairs

We provide short-term CXO-level support to help you successfully navigate a significant inflection point. We are implementors and action-takers, as well as providing advice and being the CEO's ally. Unlike other short-term C-level providers, we work as a team, so you tap into a wide array of experience and expertise.