Due Diligence Solutions

ELIQUENT understands the complex regulatory environment within which life sciences transactions take place. ELIQUENT regularly partners with investors to evaluate potential issues and regulatory risks that may be identified during life sciences transactions. Our team of experts provide investors with extensive research, regulatory history assessments, and recommendations on the path forward for potential deals that require regulatory risk analyses before and after decisions and transactions

ELIQUENT’s due diligence services are more than a compilation of public data – we go a step further by enabling the vast institutional knowledge of our regulatory experts to provide in-depth analyses tailored to our clients’ specific needs. ELIQUENT’s multidisciplinary team uses its extensive expertise to perform risk assessments that take into account business objectives, transaction timelines, and the industry and regulatory landscape. The result is an unbiased expert analysis of both expected and unexpected regulatory risks

Unlocking Success

ELIQUENT’s due diligence solutions are tailored to the unique needs of the life science sector – empowering clients to confidently navigate opportunities. Our comprehensive services support strategic decision making for both buy-side and sell-side transactions.

Buy-Side Transactions

Our buy-side due diligence solutions empower investors with comprehensive insights to confidently navigate opportunities and achieve strategic objectives.

Scientific Rigor

With experience across the landscape of therapeutic areas and modalities, the ELIQUENT team provides the technical and scientific expertise investors need when considering a life sciences transaction. 

Risk Mitigation

Investing in the life science arena comes with inherent risks. We go beyond identifying risks by providing strategic recommendations to mitigate them effectively, safeguarding your investments.

Market Intelligence

ELIQUENT’s industry knowledge and regulatory expertise offers invaluable market insights, enabling you to anticipate trends, assess competitive landscapes, and capitalize on emerging opportunities.

Sell-Side Transactions

ELIQUENT provides clarity and an objective viewpoint, thereby maximizing value in a transaction, and empowering companies to make informed decisions.

Program Roadmap

ELIQUENT partners with companies to evaluate, prioritize, and optimize commercial assets and programs. By identifying areas for improvement and value enhancement, our team of experts create a roadmap to maximize the prospects for successful regulatory outcomes.

Risk Assessment

Our in-depth assessments go beyond identifying regulatory risks – the ELIQUENT team delivers strategic and technical recommendations for system-wide quality and regulatory enhancements.

Industry Insights

ELIQUENT provides companies with critical insights by monitoring and analyzing the life sciences sector for emerging trends, evolving regulatory reforms, and changes to the competitive landscape.

Supported more than 160 diligence deals since 2019

120+ diligence projects focused on

drug, biologic, vaccine, or CGT

Partnered on diligence engagements with 25+

of the top healthcare private equity firms globally

Diligence support for over $11 billion in realized client investments

Strategic & Technical Guidance

ELIQUENT’s due diligence services include research and analysis of the following potential data sources:

Product Development

Evaluation of clinical development plans, including review of clinical and nonclinical data, FDA correspondence, safety reporting, and sponsor proposals for future clinical studies.

Pathway Evaluation

Determine eligibility for special designation(s), including priority review, fast track, accelerated approval, breakthrough therapy designation, and regenerative medicine advanced therapy designation.

Regulatory Submissions

Review of pending product submissions to assess completeness and approval prospects, including FDA information requests, mid and late-cycle meetings, advisory committee outcomes, labeling negotiations, and inspectional results.

Compliance Status

Analysis of target company’s FDA compliance and enforcement history, including a review of FDA correspondence relating to compliance matters and identification of outstanding or pending compliance and remediation actions.

Distribution & Supply Chain

Assessment of import-export practices, supply chain audit reports, outsourcing arrangements, and distribution procedures.

Preclinical & Clinical Quality Systems

Assessment of compliance with FDA current good laboratory practice (GLP) and good clinical practice (GCP) regulations. 

Reporting Requirements

Confirm that the target company has complied with all requirements for registration, authorization, filing, and listing associated with approved products, including user fee payments and fulfillment of postmarket obligations. 

Quality Manufacturing

Evaluation of the target company’s compliance with FDA quality and manufacturing regulations related to inspections, standard operating procedures, quality assurance activities, and relevant contract manufacturers.

Adverse Event Reporting

Review of adverse event reports (AERs) and good manufacturing practice complaints to ensure that the target company has taken appropriate measures for review and investigation. 

Marketing & Promotion

Evaluation of promotional practices and marketing materials, including labeling claims, promotion of unapproved products or off-label uses, and related FDA correspondence or enforcement actions. 

Regulatory Resources.

Unlock ELIQUENT Excellence.

View or download ELIQUENT’s Due Diligence Solutions Information Sheet to explore our integrated service offerings and learn how our team of experts unlocks regulatory excellence.

Due Diligence Info Sheet

View or download ELIQUENT’s Due Diligence Solutions Information Sheet to explore our integrated service offerings.

Due Diligence News Release

Read ELIQUENT’s news release announcing the firm’s expanded Due Diligence Solutions.

Unmatched Expertise

ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly throughout the product lifecycle. Together, we create a full-service model that equips clients with a premier regulatory resource.


ELIQUENT’s life science experts work as teams specializing in drugs and biological products, medical devices and combination products, and advanced therapies. Together, they provide strategic and technical guidance on product development, regulatory review, and postmarket requirements across therapeutic areas, modalities, and global markets.

& Compliance

ELIQUENT provides services that are recognized as best in class by companies seeking to strengthen their quality management systems. Experts specialize in corporate quality and compliance systems; FDA inspections, communication, and enforcement processes; and the complete spectrum of compliance and enforcement-related actions.


ELIQUENT’s comprehensive capabilities are amplified by a network of ready to deploy professionals with an expansive range of expertise. The hand-picked global consultant network supports and enhances ELIQUENT’s due diligence solutions by delivering the expertise, credentials, and language- or region-specific skill set clients need to unlock success.

ELIQUENT Experience

Explore real-world examples of ELIQUENT’s expertise with our case studies. Discover how we’ve helped clients overcome challenges, achieve their goals, and drive tangible results. From innovative strategies to impactful solutions, each case study offers valuable insights into our approach and capabilities.

CASE STUDY: Venture Capital Investment
in Novel Bacteriophage Development Space

Venture Capital Investor conducting diligence on an early-stage biopharmaceutical company engaged in a unique and challenging development space focused on novel natural and engineered phage therapies that target specific pathogenic bacteria. READ MORE

CASE STUDY: Private Equity Diligence of Multiple Excipient
Manufacturing Operations & Integration Potential

Private equity investor required quality/compliance expertise to assess excipient manufacturing operations, ramifications from a prior FDA enforcement action, and quality systems across numerous facilities both on-site and through a desktop audit.  READ MORE

CASE STUDY: Global Medical Device Firm’s Acquisition &
Integration of Another Medical Device Manufacturer

Engaged by a global medical device company to assess the regulatory and compliance risks/opportunities associated with the product portfolio and pipeline of another global medical device company for a potential acquisition. READ MORE

CASE STUDY: Sell-Side Assessment of Vaccine Manufacturer
Preparing for Third-Party Diligence Following Key Data Release

Support an early-stage biotech company by providing a clinical and regulatory review in anticipation of third-party diligence following proof-of-concept data release. Engagement included strategic clinical and regulatory review of its development history…READ MORE

Ready for regulatory clarity? Contact us.