EMERGING LIFE SCIENCE (ELS) CORPORATE LAUNCH

There will be chaos - the trick is managing it well.

  • Major business transformation from research to commercialization.
  • Rapid (and correct) key business decisions.
  • Key decision makers often not hired when you need them.
  • Build-out of a complex commercially ready infrastructure from scratch.
  • Priorities changing and pulling from multiple directions.
  • Too much to do, too little time without a full team on board.
  • Constant onboarding of new people, with new opinions, threatens progress.
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We partner with Emerging Life Science leadership teams to design and build your business operations - often from scratch. This means all the functions, processes and systems necessary to manufacture, market, sell, receive revenue and ultimately address the unmet needs of patients with your newly approved product.

 

For a quick snapshot of Mission Critical Business Activities: Click Here
 

We understand the reality of building a company on a tight timeline.

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Senior leaders need to focus on strategies, yet have a handle on the details.

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Alignment and momentum must be maintained across multiple work streams riddled with complexity and interdependencies.

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Decisions need to be made quickly with confidence, without perfect information.

We make your mission our mission.

We’ve been through this many times. Clients look to us to provide practical guidance on strategies, watch-outs and lessons learned. They ask us to roll up our sleeves to manage the chaos and implement the solutions needed on a regulatory-driven timeline.

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Given the regulatory timeline, when do clients engage us?

The short answer: it depends. Every client approaches us with a unique situation.

Ideally, we start working with a client 16-24 months prior to FDA approval. We’ve learned that starting early on planning and preparation provides leadership with more options and control, and reduces the amount of last-minute heroics in the final months leading up to approval.

In reality, clients engage us at all different points along the regulatory timeline. 

Depending on the amount of time you have until approval, we know how to adjust to meet the reality of the situation.


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We have the team. We have the talent.

Here’s a snapshot of what SVA Bio-Ops can do for your company:

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ELS program health check – we’ll figure out where you are, help you see what’s next and determine your risk.

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We’ll mobilize a program that includes the coordination and management of work streams across all business functions. 

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We’ll help you get the work done - implementing new processes and systems as well as onboarding and training new members of your team.

Successful implementation at high velocity requires mutual trust and deep collaboration. Here’s our promise to you…

 

  • We engage at the leadership level, providing candid observations with directionality for confident decision making
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  • We come with a full tool box of program management methods, templates and lessons learned.
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  • We know how to manage the life-blood of a commercialized ELS firm - your data assets.
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  • We are completely transparent with our work output, schedules and billing.
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  • We bring an extensive network of planning, leadership and execution resources - both business and technical.
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  • We have experience with commonly selected vendors and suppliers to inform your decision making.
  • We’ve managed and/or implemented over 80% of the work streams across all functions in your business.
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  • We become an extension of your company and make your success our priority.
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  • We adapt to the ebb-and-flow of demands using a highly skilled, experienced team that will execute without delay or drama.
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  • We have a stock of strategies and solutions to overcome ‘launch killers.”
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  • We help you as leaders stay forward in your business.
 

SVA Bio-Ops operates on a foundation of core values and practices that are ethical and predictable and start with limited term, low risk engagements with new clients to determine mutual compatibility. 

Ultimately our business succeeds with the success of our clients. We take on a limited number of ELS engagements so we can truly adopt your mission and our leadership team can be intimately involved in achieving measurable results for you.

If this is intriguing to you, contact us to schedule a meeting and we’ll be glad to listen and learn more. 

 

Our Commitment to Our Clients:

If our work creates no value to your business…don’t pay the bill.

 


See how we provided Exact Sciences with Measurable Results:

LEARN MORE

Exact Sciences Measurable Result

Exact Sciences


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