Disclaimer

Last Updated: January 2024

1. General Information Disclaimer

The content on this website, including but not limited to text, graphics, images, videos, and other materials, is provided for general informational purposes only. While we strive to ensure the accuracy and timeliness of the information presented, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability of the information, products, services, or related graphics contained on the website.

Any reliance you place on such information is strictly at your own risk. In no event will ProDigitalConsulting be liable for any loss or damage arising from the use of this website or its content.

2. Professional Services Disclaimer

2.1 No Guarantee of Results

ProDigitalConsulting provides strategic consulting services based on our professional expertise, industry knowledge, and analytical methodologies. However, we do not guarantee specific outcomes, results, regulatory approvals, commercial success, or financial performance related to our consulting services or recommendations.

The pharmaceutical and biotechnology industries are complex and subject to numerous variables beyond our control, including but not limited to:

• Regulatory decisions and policy changes
• Clinical trial outcomes and safety data
• Competitive market dynamics and new product launches
• Healthcare system reforms and reimbursement changes
• Economic conditions and market forces
• Scientific advancements and technological disruptions

2.2 Strategic Recommendations

Our strategic recommendations and analyses are based on information available at the time they are provided and reflect our professional judgment and expertise. These recommendations should be considered as one input into your decision-making process and should not be the sole basis for critical business decisions.

We encourage clients to supplement our recommendations with their own due diligence, internal analysis, and consultation with other relevant experts and advisors.

3. Not Legal, Medical, or Regulatory Advice

3.1 Legal Advice

The information and services provided by ProDigitalConsulting do not constitute legal advice. We are not a law firm, and our consultants are not attorneys (unless specifically identified as such in individual engagements). For legal matters, including regulatory compliance, intellectual property, contracts, and litigation, you should consult with qualified legal counsel.

3.2 Medical Advice

ProDigitalConsulting does not provide medical advice, diagnosis, or treatment recommendations. Our services focus on strategic and commercial aspects of pharmaceutical product development and market access. Clinical and medical decisions should be made by qualified healthcare professionals and researchers.

3.3 Regulatory Advice

While we provide strategic guidance on regulatory pathways and market access strategies, we are not a regulatory consulting firm and do not provide formal regulatory advice or represent clients before regulatory agencies. Clients should work with qualified regulatory affairs professionals for regulatory submissions and compliance matters.

4. AI and Predictive Models Disclaimer

4.1 ElevioSight and Predictive Analytics

Our proprietary ElevioSight predictive models and AI-powered analytics are designed to provide insights and forecasts based on historical data, market trends, and analytical algorithms. These models are tools to support strategic decision-making but have inherent limitations:

• Predictive models are based on assumptions and historical patterns that may not hold in the future
• Forecasts are probabilistic and subject to uncertainty and error
• Models cannot account for unforeseen events, black swan occurrences, or paradigm shifts
• AI-generated insights should be validated and interpreted by human experts
• Model accuracy depends on the quality and completeness of input data

Clients should use our predictive models and AI-powered insights as decision support tools, not as definitive predictions of future events.

4.2 Data Limitations

Our analyses rely on data from various sources, including public databases, proprietary research, and client-provided information. While we take reasonable steps to ensure data accuracy and reliability, we cannot guarantee the completeness or accuracy of all data sources. Inaccurate or incomplete data may affect our analyses and recommendations.

5. Confidentiality and Third-Party Information

5.1 Confidential Information

Any confidential information shared with ProDigitalConsulting during engagements will be treated in accordance with our confidentiality agreements and professional standards. However, clients should be aware that:

• We may develop general knowledge, skills, and experience from our work that becomes part of our consulting capabilities
• Non-confidential insights and methodologies may be applied to other client engagements
• We may be required to disclose information pursuant to legal requirements or court orders

5.2 Third-Party Information

In the course of our work, we may reference or incorporate information from third-party sources, including published research, market reports, and industry databases. While we strive to use reputable sources, we cannot independently verify all third-party information and are not responsible for errors or inaccuracies in such sources.

6. External Links Disclaimer

Our website may contain links to external websites, resources, or third-party content that are not owned, operated, or controlled by ProDigitalConsulting. We have no control over the nature, content, and availability of these external sites.

The inclusion of any links does not necessarily imply a recommendation or endorsement of the views expressed within them. We are not responsible for the content, privacy policies, or practices of external websites. You access external links at your own risk.

7. Changes and Updates

The pharmaceutical and biotechnology industries are dynamic and constantly evolving. Information on our website and in our services may become outdated or superseded by new developments. We reserve the right to:

• Modify, update, or remove content on our website without notice
• Change our service offerings, methodologies, or approaches
• Update our analyses and recommendations in light of new information

We encourage users to verify that they are accessing the most current information and to contact us if they have questions about the currency of specific content or recommendations.

8. No Client-Advisor Relationship

Accessing our website, viewing our content, or contacting us for general information does not create a client-advisor relationship or any obligation on our part to provide services. A formal consulting engagement requires a written agreement signed by both parties outlining the scope, terms, and deliverables of our services.

Any information shared with us prior to a signed engagement agreement should not be considered confidential unless covered by a separate non-disclosure agreement.

9. Conflicts of Interest

ProDigitalConsulting may work with multiple clients in the pharmaceutical and biotechnology industries, including companies that may be competitors or have overlapping interests. While we maintain strict confidentiality protocols and ethical standards to manage conflicts of interest, clients should be aware that:

• We may have concurrent engagements with other clients in similar therapeutic areas or markets
• Our general knowledge and expertise may be applied across multiple clients
• We will disclose potential conflicts of interest when appropriate and material

Specific conflict management procedures will be outlined in individual engagement agreements.

10. Limitation of Liability

To the fullest extent permitted by law, ProDigitalConsulting disclaims all liability for any direct, indirect, incidental, consequential, special, or punitive damages arising from:

• The use of or inability to use our website or services
• Reliance on information provided on our website or in our services
• Errors, omissions, or inaccuracies in our content or recommendations
• Unauthorized access to or alteration of your transmissions or data
• Any other matter relating to our website or services

This limitation applies whether the alleged liability is based on contract, tort, negligence, strict liability, or any other basis.

11. Geographic Limitations

Our services and expertise focus primarily on major pharmaceutical markets, including the United States, European Union, and other developed markets. While we may provide insights on emerging markets and other geographies, clients should supplement our recommendations with local expertise and knowledge for markets where we have limited experience.

Regulatory requirements, reimbursement systems, and market dynamics vary significantly across countries and regions. Our recommendations should be adapted to local contexts with the assistance of appropriate local advisors.

12. Independent Contractor Relationship

ProDigitalConsulting operates as an independent consulting firm. Nothing in our services or engagement creates an employment, partnership, joint venture, or agency relationship between ProDigitalConsulting and our clients. We retain control over how we perform our services and are responsible for our own business operations, taxes, and compliance obligations.

13. Testimonials and Case Studies

Testimonials, case studies, or success stories presented on our website represent the experiences of specific clients in particular circumstances. Results may not be typical and should not be interpreted as guarantees of similar outcomes for other clients. Each consulting engagement is unique and results depend on numerous factors specific to the client, product, and market conditions.

Testimonials and case studies may be edited for length, clarity, or confidentiality purposes. Some client names and identifying details may be anonymized to protect confidentiality.

14. Contact Information

If you have questions or concerns about this Disclaimer or need clarification on any matters, please contact us:

This Disclaimer should be read in conjunction with our Privacy Policy and Terms of Use. By using our website or services, you acknowledge that you have read, understood, and agree to this Disclaimer.