REGULATORY DD SERVICES FOR 'BIG' & 'SMALL' MOLECULES 

THE VALUE OF REGULATORY DUE DILIGENCE (RDD)

• RDD is the comprehensive appraisal of an asset undertaken by a prospective buyer or licensee, to establish the true development and regulatory status of an asset(s) and to correctly evaluate the regulatory risks and underlying assumptions associated with a transaction.

• RDD serves to objectively confirm all material regulatory facts related to the acquisition of an asset, product or company, prior to a transaction.

• RDD serves to inform investment decisions associated with an specific transaction, and can lead to a substantial revaluation of the asset(s), or the deal itself.

• RDD is typically a multidisciplinary, cross-functional exercise which requires expertise from all key functions.

• RDD is always closely related to the QA & Manufacturing investigation of the DD process.

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REGULATORY DD TRAINING FOR EXECUTIVES

THOROUGH REGULATORY DD IS ESSENTIAL  FOR BUSINESS DEVELOPMENT (BD) SUCCESS:

• BD executives need to develop a deeper knowledge of the Regulatory DD process, content and hurdles.

• BD executives need to understand the challenges and opportunities presented by an enhanced Regulatory DD.

• BD executives need to understand the implications of regulatory or QA deficiencies.

• BD executives need to support associates in developing positive and productive interactions with regulatory and QA DD team members.

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BD EXECUTIVES NEED TO KNOW:

• How to prepare the company for a Regulatory DD process?

• What they should expect from their Regulatory DD team?

• How to prepare / enable the Regulatory Team for efficient DD?

• How to structure an affective Regulatory DD team? 

• How to effectively structure the Regulatory DD process? 

• How to prepare the counterparty for effective Regulatory DD collaboration? 

• What they should expect from the counterparty? 

• The scope of a thorough Regulatory DD? 

• Common pitfalls and errors in Regulatory DD and how to avoid them.

• How to structure a Regulatory DD report? 

• What is the most effective way to interpret the Regulatory DD report? 

• How to communicate and integrate findings in the transaction process? 

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REGULATORY DD TRAINING FOR TEAM MEMBERS

THE GRALC REGULATORY DUE DILIGENCE COURSE IS MADE UP OF 6 KEY SECTIONS

1. The Regulatory Due Diligence Team

2. The Regulatory Due Diligence Team

3. Briefing the Regulatory Due Diligence Team 

4. Structuring Regulatory Due Diligence and set Deliverables

5. Scope of Regulatory Due Diligence and Time

6. Outcome – RDD report interpretation workshop / presentation

7. Common Errors and Pitfalls

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