Regulatory &
Scientific Affairs

SPRIM's global access to Regulatory and Scientific information together with our unique experience in dealing with Regulatory and Scientific Bodies in America, Europe and Asia, allow SPRIM to address all local regulatory and scientific issues.
SPRIM assists its clients in every step of the regulatory process, from submission through to claim approval.

Client Aims	SPRIM Services
Developing Regulatory and Scientific Consensus Product / Ingredient / Compound Registration Labeling review, Advertising approval Health claim approval Devising regulatory dossiers	Scientific Regulatory Pre-Check and Screening Mapping & Networking Activities Regulatory Process Assistance Global Customized Strategies for Product Launch

Scientific Regulatory Pre-Check and Screening

“What does the FDA, ANVISA, EFSA or KFDA have in common? Our RSA platforms and teams will help you to find the right paths to address and expedite complex Regulatory and Scientific Issues.”

Mr. Ivan Jarry, Managing Partner, SPRIM, Bangkok

 

Regulatory and Science Pre-evaluation:

• Scientific Screening
• Analysis of product supporting/scientific data
• Study of proposed packaging, labeling, claim, communication material
• Analysis of local product regulation and practices
• Validation with key external experts

Mapping & Networking Activities

Mapping of key stakeholders:

Authorities, NGOs, Associations, Commissions, KOLs, Media

Targeted scientific network activities:

Data Building, Networking, Road Shows, Public relations, Event participation, Spokespersons, Workshops

RSA Endorsement

Approach and Message endorsement Strategy

Consensus Generation Strategies

Scientific Defense (see IQM)

Regulatory Process Assistance

Preparation of regulatory dossiers:

• Analysis of required documentation
• Data mining
• Compilation of data
• Redaction of final dossier
  
  

External Pre-Validation / Endorsement of dossier

before submission

Dossier Submission:

• Presentation of Dossier to local authorities
• Follow up of dossier status within local regulatory body internal process (answer to questions and requests)

Global Customized Strategies for Product Launch

• Analysis of market specific requirements for product launch
  
  
• Identification of locally required supporting data:
  study reports, pre-clinical and clinical studies, analyses

  Definition of global regulatory paths for approval: including cost analysis, timings and probability of success.

• Customized recommendation