AlvaMed quickly uncovered the facts, confirming the suspicions of the pharma company’s team. The client team additionally requested AlvaMed to present our findings to the company’s “pain management” senior management.
Many factors go into the decision to acquire a company or a new product line. Potential compliance risks must be considered during acquisition planning and AlvaMed’s seasoned team can help you evaluate the pros and cons by providing due diligence across the regulatory, quality and clinical areas. Understanding and overcoming these compliance challenges allows you the ability to move forward successfully.
Our experts partner with our client’s due diligence team to meet with the acquisition target’s senior management.
AlvaMed’s regulatory experts review product site and market registrations, regulatory agency interactions, product labeling and adverse event reporting. |
AlvaMed’s clinical experts review the status of clinical data in support of both current products and future product launches
AlvaMed’s quality experts review recent inspection and internal audit findings, quality system status indicators (such as CAPA), nonconformance and complaint data, and product quality and manufacturing documentation.
AlvaMed quickly uncovered the facts, confirming the suspicions of the pharma company’s team. The client team additionally requested AlvaMed to present our findings to the company’s “pain management” senior management.
CASE STUDY
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
Complexity of the industry: Medical device regulations, intellectual property laws, and financial analysis demands specialized knowledge. Investors often need a team with expertise in these areas and understanding of the specific niche the company operates in.
Internal vs. external resources: Balancing the use of internal team members with external consultants helps leverage both existing knowledge and specialized expertise. External advisors can bring fresh perspectives and access to industry-specific data.
Role of advisors: Different advisors such as like legal counsel, regulatory consultants, and financial analysts play crucial roles in assessing different aspects of the company. Choosing the right team with relevant experience is key.
Company size and product maturity: Early-stage companies with novel devices require different assessment parameters than established companies with marketed products. Adapting the due diligence scope to the company’s stage optimizes resource allocation.
Risk identification and prioritization: Not all areas carry equal weight in terms of potential risks. Identifying and prioritizing areas with the highest impact on the investment decision guide the allocation of resources during the due diligence process.
Focus areas based on investment goals: Are you looking for short-term gains or long-term growth potential? Tailoring the due diligence focus to align with your investment goals ensures you gather the most relevant information.
Clear communication and timelines: Setting clear expectations and timelines with the target company upfront establishes trust and minimizes disruptions to their daily operations.
Phased approach: Breaking down Dividing the due diligence process into phases instead of one overwhelming task. This allows for gathering initial information efficiently and focusing on deeper dives where necessary.
Data room setup and access control: Securely setting up a data room with controlled access ensures confidential information is shared efficiently and minimizes the burden on the target company.
Throughout Mark’s career he has supported and managed teams responsible for conducting due diligence of an acquisition.
Ready to learn more about how AlvaMed can assist with due diligence efforts?
Schedule a time to discuss with Mark.
