Strategic Consulting

Strategic Consulting for Life Science Companies

Full service problem-solving starts with the right strategy. Validant’s partners are subject matter experts in the many facets of regulatory, compliance, and quality requirements to develop and market drugs, medical devices, and diagnostic products globally.

Applying deep experience earned through thousands of engagements, we tailor our proven methodologies to the nuances of your product, team, geographic region, and specific initiative.

  • Regulatory Strategy
  • Process Development Strategy
  • Quality Management Systems (QMS) Strategy
  • Data Integrity Strategy
  • In-House vs. Contract Supplier Strategy
  • M&A Strategy
  • Design Review

Actionable Strategies
Spanning the Product Lifecycle

Our strategies are crafted to meet you where you are while advancing you to the next level.

Preclinical Strategies

Selecting the appropriate pathway to market is the first critical step to optimizing your product’s likelihood of and time to approval. We help you weigh your regulatory options and put initial study designs in place.

For more on our preclinical consulting services, click here.

Clinical Strategies

The right clinical strategy is critical to accelerate your promising product to market. Our team is comprised of former regulators and we apply an insider’s understanding of regulatory agencies’ nuanced processes and global requirements to help you ensure a timely, optimal approval outcome.

For more on our clinical consulting services, click here.

Manufacturing Strategies

Transitioning from the laboratory to manufacturing requires confirmation that your methods are reproducible in a GMP environment, and that you have documented evidence of having the necessary controls in place to assure quality. Validant’s GMP subject matter experts help you develop appropriate strategies to meet compliance demands, and will also offer fast guidance to address and remediate health agency enforcement actions if they arise.

For more on our GMP consulting services, click here.

Distribution Strategies

Validant will help you expertly navigate regulatory requirements related to post-market surveillance, developing strategies to ensure a robust quality management system is in place to cover your supply chain end-to-end, and instill confidence in your brand’s quality in the market.

For more on our GDP consulting services, click here.

Maximize Quality

Practical Strategies to Maximize Quality

Our team is comprised of former industry operators as well as regulators from global agencies. We combine their perspectives to ensure your developed strategies are both pragmatic and stand up to the scrutiny of all relevant health agencies.

Meet Your Team

Get to know the Validant leaders you’ll be working with.

Our Leadership


Validant at a Glance

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How can we help you?

Tell us what you’re looking to achieve.
We’ll put our experience to work on your specific problem.

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