Execution

Alira Health knows how to leverage mergers and acquisitions to help healthcare and life science companies grow. We provide a more strategic M&A approach based on our extensive knowledge of the commercial drivers, market players, and growth trends in your space.

We work with you to identify and select appropriate investors and investments so you can close on the opportunities most likely to deliver long-term profitability and value.

Structured for success

Our M&A advisors are also scientists, doctors, and MBAs who fully understand the intricacy of corporate finance requirements. They have a successful track-record of helping healthcare and life science companies of all sizes through the complicated and often delicate operations associated with M&A transactions.

At Alira Health, we know how important it is for healthcare and life science companies to collaborate with the right partners at the right time. So, we simplify the process of helping you to engage strategically with business partnerships, strategic alliances, product/technology licensing, funded research, co-development agreements, co-marketing, co-promotion arrangements, and joint venture constructs.

We lead your partnership and alliance activities by helping you prepare for engagements with a more comprehensive understanding of your options. We also work with you to ensure a successful negotiation that’s thoroughly researched and developed.

The difference is in our people, who advise you with a knowledge of both finance and science to fully understand the complexity of your transaction.

What can we do for you?

  • Prepare financial analyses.
  • Identify potential strategic partners.
  • Participate in transaction structure and negotiations.

Capital is the lifeblood of innovation, so Alira Health works hard to help connect you with the financial tools you need to fuel invention and growth. Our financial and business experts are also scientists, doctors, and engineers who understand how to use monetary tools to your advantage to move your ideas into execution.

Let us leverage our expertise in growth capital and expansion financing so you can:

  • Find new capital sources.
  • Make valuable industry connections.
  • Gain an accurate financial perspective.

Our strong understanding of the challenges and opportunities within the pharma and medical device sectors can help you execute development plans that create financial success.

Commercializing on pharma innovation can be a challenge, especially in today’s global markets where competition is fierce. In- and out-licensing services from Alira Health can help your business leverage strategic license agreements to expand your share of the pharma market.

  • Out-license: Let us help you find strategic alliances to license your innovation.
  • In-license: Acquire a licensed pharma product to fill the gaps in your product portfolio.

Why Alira Health for in/out licensing?

We know how to license pharma to your advantage. Our consultants are business and finance professionals who have science backgrounds, so they know what’s important in pharma and where market opportunity is headed.

We work with you to maximize your licensing rewards — and mitigate your risks, with a full-service offering that includes strategy, execution, enforcement, and monitoring.

What can we do for you?

Rely on our licensing expertise for:

  • Partner and contract audits.
  • License and portfolio management and enforcement.
  • Compliance monitoring for license distribution and pricing.
  • Resolution of royalty disputes.
  • Royalty agreement drafting.
  • Alliance monitoring and management.

Leverage our network of experts to advance your corporate and innovative initiatives. With our connections, you can promote your product and business with the expert guidance of advisors who are known, established, and respected.

Kick start for start-ups

Take your healthcare and life science inventions to the next level. Let us connect you with stakeholders who can facilitate the review and approval you need to advance. Our advisors are scientists, engineers, clinicians, and business leaders who know how to bring new ideas to life.

A connection to expertise

Maximize your business reach. Tap into Alira Health’s fifteen years of experience and know-how in six locations across the United States and Europe. We can work on your behalf to target and collaborate with influencers to extend your brand and corporate identity.

Need marketing?

Let us help you identify and leverage your market differentiators and craft messaging to promote your brand and products to key decision makers and audience segments.

Need business development?

Make more valuable connections with us. Get the advice, coaching, and leadership to bring your brand and products to the right markets at the right time.

Don’t let missteps in due diligence get in the way of your business goals. Rely on Alira Health for the unbiased guidance you need to navigate FDA and European regulatory requirements with less risk and better outcomes.

Innovation moves fast, and you can’t afford to let gaps in clinical and compliance knowledge slow your momentum. Our consultants are doctors, scientists, engineers, and business professionals who can help you navigate compliance with strategic approaches to dealing with notices, recalls, and regulatory changes, so your business doesn’t get blindsided.

Compliance awareness

As practitioners in the field who know the ins and outs of compliance, we’re uniquely qualified to help you develop proactive strategies to gain approval by the FDA, and European regulatory bodies — and to drive clinical adoption of your products.

Regulatory skill

We are a team of medical affairs professionals who lead peer-reviewed publications and who have 100+ years of combined experience across the pharma, life sciences, medical technology, and healthcare IT industries. They know how to conduct clinical evaluations and perform scientific due diligence to help you satisfy compliance with confidence and control.

Design and implement a competitive and cost-effective regulatory strategy. Alira Health has a network of regulatory advisors who can help you develop regulatory submission strategies with your business objectives in mind. Rely on us to balance risk, increase speed, and decrease costs associated with:

  • Orphan Designations
  • Breakthrough Designations
  • Fast Track Designations
  • Adaptive Design Programs
  • Direct-to-patient Programs
  • Hybrid Programs
  • PRIME Programs

Dossier submission simplified

We work with you to prepare, review, and file submission documents to address regulatory concerns and minimize inquiries associated with:

  • Pre-submission support documents
  • 510(k) Premarket Notifications
  • Investigational Device Exemption Applications (IDEs)
  • Premarket Approval Applications (PMAs)
  • Investigational New Drug Applications (INDs)
  • 513(g) Requests for Classification
  • Biologic License Applications (BLA)
  • Design Dossiers for CE Mark

Reliable regulatory representation

Alira Health experts serve as a liaison for clients in active negotiation with regulatory bodies, providing expertise and guidance on:

  • FDA Establishment Registration
  • FDA US Agent for Foreign Establishments
  • EU Authorized Representative

Part of passing regulatory scrutiny is conducting clinical trials to demonstrate the efficacy and safety of your drug or medical device. The design and endpoints of your clinical trials can make or break your business. Alira Health can design and manage clinical trials to help move your products to regulatory body review – quickly and affordably.

Our consultants are medical affairs and scientific experts who are also biochemists and certified lab animal technicians who know how to conduct the pre-clinical and clinical research needed to satisfy regulatory requirements. Our advisory firm provides the full-service solution you need to navigate your way through every stage of the product lifecycle, from clinical trial through the drug development and approval process.

Preclinical trials

How effective is your product? Find out with our pre-clinical research conducted in our state-of-the-art Drug and Device Discovery lab (3DL) that adheres to established guidelines sure to pass regulatory scrutiny.

We can design and implement preclinical studies for drug or device safety. And for medical devices, we can provide preclinical testing for medical products to test safety and efficacy while also providing expert opinion on product design, strategy, and management.

Clinical trials

Need a clinical trial? Let us help you achieve your U.S. and international regulatory approval and marketing goals for your pharma or medical device. We have the resources and the expertise to manage the clinical trials with less cost and time to your business – and complete adherence to FDA requirements.

There’s nothing more complex than the rapidly changing healthcare and life science clinical and regulatory environment. Rely on Alira Health for a full-service approach to clinical communication and education advisory services. We keep your business on the right side of regulatory compliance while effectively communicating your product to healthcare professionals.

Marketing review

Concerned about making a misstep in claims that fail to communicate the proper balance of evidence? Alira Health can work with you to review and optimize your clinical communication strategies to ensure that your marketing messages are on target with regulatory requirements. Our medical affairs consultants can review your marketing materials and labels to ensure they adhere to mandates set for transparent and effective communication required for product approval, reimbursement, and market adoption.

On-demand expertise

Fill the leadership gaps in your healthcare or life science company so you can advance innovation. Alira Health can provide on-demand Chief Medical Officer (CMO) or Chief Technology Officer (CTO) services to lead your business or product from idea to market adoption.

What can our clinical and education services do for you?

  • ‍Provide clinical expertise and training to your sales force.
  • ‍Educate your staff on clinical protocols and practices.
  • ‍Train you on how to communicate your value to healthcare professionals.
  • Lead and advance your healthcare and life science innovation.
  • Close gaps in knowledge or corporate leadership.