Regulatory

The Life Sciences industry is growing ever more complex, with expanded government enforcement accompanied by new and increasingly demanding regulatory requirements. EG Life Sciences Consulting is well-positioned to assist pharmaceutical manufacturers, biotech and medical device companies in meeting these growing challenges.


 
Regulatory Submissions (ex.- Premarket Approval PMA, 510(k), CE Mark, INDs, ANDAs, etc.) and Compliance

Lead and assist client companies with product approvals and submissions for both U.S. and International markets.

 
Labeling, Advertising, and Promotional Materials Review

Review and approval of media and collateral to support commercial product launch and supply.

 
EU Medical Device Expertise

Extensive experience with international product commercialization including CE Marking, device registrations, export certificates, etc.

 
Technical File and Design Dossier Preparation

Establish required documentation to conform to the Essential Requirements for EU product approval.

 
Management of Notified Body Audits

Lead and assist client team during assessments by international regulatory body audits.

 
Remediation of FDA 483 Observations/Warning Letter/Consent Decree

Lead and assist in efforts to resolve regulatory body observations, findings and issues that have resulted in a negative business climate.