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Regulatory Compliance Services

Effectively resolving complex regulatory issues

Global industry leader in regulatory and compliance services

Flavine is proud to offer com­pre­hen­sive reg­u­la­to­ry ser­vices that are catered to your unique needs. As your pre­ferred reg­u­la­to­ry agent, we will work close­ly with you to effec­tive­ly resolve reg­u­la­to­ry issues and help sim­pli­fy the drug approval process with­in the Unit­ed States, Europe, Chi­na, India, Mid­dle East and North Africa. Our teams of reg­u­la­to­ry experts have decades worth of exper­tise work­ing with health author­i­ties such as the US FDA, EDQM, and CFDA. We under­stand how to suc­cess­ful­ly nav­i­gate the var­i­ous reg­u­la­to­ry land­scapes and assist you with your reg­u­la­to­ry and com­pli­ance requirements.

Full range of regulatory services

Our state of the art, GMP-com­pli­ant lab­o­ra­to­ry facil­i­ty in Vit­rolles, France offers com­pre­hen­sive ana­lyt­i­cal ser­vices, QC retest, and release test­ing of APIs and FDFs accord­ing to your spec­i­fi­ca­tions or com­pen­di­al. Com­ple­ment­ing our full-ser­vice QC test­ing, we also pro­vide robust method devel­op­ment, val­i­da­tion, and trans­fer of phar­ma­ceu­ti­cals and raw materials.

Regulatory Compliance

  • GDUFA Facil­i­ty Self-iden­ti­fi­ca­tion fil­ing and annu­al updates
  • Estab­lish­ment Reg­is­tra­tion SPL fil­ing and annu­al updates
  • cGMP audits and reme­di­a­tion plans
  • On-site sup­port for nation­al and inter­na­tion­al reg­u­la­to­ry author­i­ty audits
  • Inspec­tion obser­va­tion respons­es and CAPAs
  • Ini­ti­ate GMP facil­i­ty inspec­tion for Euro­pean Union

Labeling

  • Review of label­ing to com­ply with reg­u­la­to­ry stan­dards and cus­toms clear­ance requirements
  • NDC Label­er Code SPL filing
  • NDC Prod­uct List­ings SPL fil­ing and rou­tine updates

Master File and Dossier Preparation

  • Com­pile and pre­pare elec­tron­ic files in eCTD for­mat in sup­port of mas­ter files (DMF, VMF, and EDMF/ASMF) as well as CEP/COS
  • Prepa­ra­tion and fil­ing of FDF dossier
  • Rep­re­sent API man­u­fac­tur­er dur­ing inter­ac­tions with reg­u­la­to­ry authorities
  • Sub­mit files elec­tron­i­cal­ly through estab­lished gateways
  • Pro­vide tech­ni­cal assis­tance with defi­cien­cy responses
  • Assist with life­cy­cle man­age­ment includ­ing amend­ments, annu­al reports, LOAs, etc.
  • Offer full com­pre­hen­sive ser­vices for Chi­nese Drug Mas­ter File (DMF) reg­is­tra­tion and maintenance