Export Products

Global Countries

Regulatory

Our experienced in-house regulatory team ensures accurate, high-quality product registration dossiers. With expertise in the field, we have successfully prepared over 250 dossiers, offering access to our extensive dossier library. We also handle CTD/ACTD dossier preparation as dedicated projects.

  • ACTD Dossiers
  • CTD Dossiers
  • Dossiers as per specific Guideline of all countries
  • Bio-Equivalence Studies with GLP certified clinical centers (BE Study)
  • Pharmacokinetic Studies
  • Drug master Files (DMF)
  • Site Master File
  • Electronic Submission of Dossiers with all supporting documents

Export Products

Certification

WHO GMP
WHO GMP
EU GMP
EU GMP
MOH RUSSIA
MOH RUSSIA
MOH UZBEKISTAN
MOH UZBEKISTAN
MOH  UKRAINE
MOH UKRAINE
FDA PHILIPPINES
FDA PHILIPPINES
MOH  LIBYA
MOH LIBYA
NAFDAC NIGERIA
NAFDAC NIGERIA
MOH RWANDA
MOH RWANDA
MOH  NEPAL
MOH NEPAL
MOH KAZAKHSTAN
MOH KAZAKHSTAN
PPB KENYA
PPB KENYA
US FDA
US FDA
MOH MOLDOVA
MOH MOLDOVA