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.
Lead and assist client companies with product approvals and submissions for both U.S. and International markets.
Review and approval of media and collateral to support commercial product launch and supply.
Extensive experience with international product commercialization including CE Marking, device registrations, export certificates, etc.
Establish required documentation to conform to the Essential Requirements for EU product approval.
Lead and assist client team during assessments by international regulatory body audits.
Lead and assist in efforts to resolve regulatory body observations, findings and issues that have resulted in a negative business climate.