The invaluable support of ProductLife Consulting in business development and licensing

We offer dedicated consulting services to support life science companies and investors in their investment and external growth activities. From target screening to due diligence (commercial, manufacturing, and regulatory) and post-merger integration support, our clients recognize the need for specific life science expertise.

We have conducted due diligence work on behalf of private equity funds, pharma, CROs, and other pharma services companies, and we can offer commercial due diligence (including access due diligence), manufacturing, and regulatory focus, combined or separately, as per our clients’ needs.

Partnering with us provides several advantages

Broad capabilities, including commercial, regulatory, access, and manufacturing

We offer the full scope of expertise needed in the life sciences, including commercial access, regulatory, and manufacturing. Our senior leaders have hands-on expertise in M&A.

e-Health commercial access and regulatory due diligence

The need

A home healthcare provider sought to enhance its services by acquiring a remote monitoring solution. ProductLife Consulting was engaged to assess market potential and identify regulatory and access risks for the prospective company.

Our approach

  1. Regulatory Approval/Technical requirements: We analyzed available data for regulatory approval, including CE Mark compliance and assessing gaps in meeting essential technical requirements.
  2. Reimbursement Potential: We evaluated the robustness of reimbursement plans relative to regulatory authorities’ requirements.
  3. Adoption Potential: Understanding potential by business line, we focused primarily on future clinician adoption of telemonitoring solutions. Additional sources of business, including selling data to pharmaceutical companies and securing funding from public health authorities for screening campaigns, were also considered.

Results

We conducted in-depth assessments of proposed dossiers, engaged key opinion leaders and experts through interviews, and provided a comprehensive analysis highlighting risk and confidence areas for each domain.

Regulatory and CMC (Chemistry, Manufacturing, and Controls) due diligence on medicines portfolio acquisition

The challenge

Following a request from a private equity fund in Saudi Arabia, a partner engaged ProductLife Consulting to conduct regulatory and CMC due diligence on a drug portfolio from a US pharmaceutical company.

Our approach

We conducted a comprehensive review of the dossier, particularly with regard to market registration, API development, manufacturing, FDA Q&A, new entrants, and filing facility transfer dossier.

Result

Upon completing the due diligence, no red flags were identified. However, several orange and yellow flags were raised, primarily related to manufacturing aspects, including API production transfer projects.

Market access due diligence for a Phase III compound

The challenge

Our client, a European pharmaceutical company, was in the final stages of considering the acquisition of a late-stage compound (Phase III development). The compound offered two potential positioning options (second or third line), and the due diligence conducted by a generalist consultancy lacked specific insights into potential pricing variations across countries.

Our approach

To address this, we conducted thorough desk research and gathered existing expertise to compile precise and comprehensive data on care pathways, standard of care, and current competitive pricing in the target regions. Additionally, we conducted expert interviews, engaging clinicians and payers to capture diverse perspectives. We emphasized specific points, such as using a clinical comparator (a low-priced product) and price comparisons.

Result

We delivered our client a comprehensive understanding of pricing-related risks and opportunities contingent on the product’s future positioning.

Post-merger integration – orphan drug medicines company

The challenge

Following the acquisition of two specialized orphan drug biopharmaceutical companies, a private equity fund embarked on merging them into a new entity. They engaged ProductLife Consulting to facilitate a seamless integration, focusing on product-related processes and risks.

Our approach

  1. Organizational assessment: We conducted diagnostics on both organizations and offered recommendations on crucial aspects such as “make or buy” decisions, process optimization, data governance, people governance, and change management.
  2. Geographical Strategy: We provided insights and recommendations regarding the new company’s expansion plans in the USA and MENA regions, including regulatory considerations and a market roadmap.
  3. Risk Evaluation: We thoroughly reviewed regulatory and CMC risks associated with the orphan drug portfolio.

Result

Our comprehensive support aimed to ensure the new orphan drug company’s successful integration and strategic positioning.