BLCMD Associates LLC
                                            

Services

All aspects of global pre- & post-marketing drug safety and pharmacovigilance

PV audits – mock audits

Audit preparation for FDA/EMA/MHRA inspections

SOP creation, review & updating

REMS & RMPs: writing & updating

Benefit-risk analyses

Mock advisory committee meetings

Data safety management boards/DMCs

Risk management

Signal detection

 

Product withdrawals & recalls

Product safety reviews

Expert reports & white papers

Change management & re-engineering

Due diligence on new product safety

PSURs

Crisis management

Regulatory safety strategy

Pre & post-marketing surveillance

Medical writing

DS & PV training

Drug Safety databases & data migration

Drug safety & PV systems & operations

Negotiations with regulators

Interim chief safety officer

Gap analyses

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