Services Offered Territories-Scope of Our Services (Global Capabilities)

• EUROPEAN UNION (UK-MHRA/EU-EMEA)
• NORTH (USFDA) /SOUTH AMERICA(ANVISA/ INH-RR etc)
• RUSSIA AND CIS
• LATIN AMERICA/CARIBBEANS-TRINIDAD/TOBAGO/BURKINO FASO
• AUSTRALIA (TGA)/ NEWZELAND (MEDSAFE)
• AFRICA/SOUTH AFRICA (NDA/PPB/TFDA/FDB/MCC..)
• WHO &ASIA (ASEANS)/INDIA (FDA)

Services offered

• Dossier writing from Module 1 to Module 5 for generic and new drug application.
• Dossier review and gap analysis
• Module 1 preparation including ERA, Readability tests, SPC, PIL, Mock Up specimen, Bridging report, Risk Management Plan and PV services
• Non Clinical and Clinical Overview and Summary.
• Module 3 Scientific Writin.
• Module 4 and 5 updation based on literature search.
• CTD to eCTD conversion/CEP/DMF fillings.
• New Submissions
  • DCP, MRP, National Submission, ANDA, NDA etc.
  • CTD dossier writing and conversion from Non CTD to NeeS-CTD/eCTD.
  • Facilitator of DCP slot booking.
  • Renewals.
  • Variation Application Type I and Type II.
  • Generation of SOPs ( Standard Operating Procedures).
  • Acting as Marketing Authorization Holder.
  • Acting as EU QP PV (qualified person and Pharmacovigilance) & PV set up. –(Work model in About us).
  • Regulatory Consultancy.
  • BIO-WAIVER expert reports.
  

Dr. Vandana is a Lead Auditor: IRQAO-ASCB-UK :IS0-9001 and EU approved.

• We provide, complete cGMP plant audits with final report for submission for API/formulations as per territory-specific MOH/FDA rules & regulations.(Regulated/non-regulated).
• We also provide training to cater to client-specific needs, specializing in Regulatory, GMP, GLP, GCP, Quality Management database, Pharmacovigilance.
• We aid support consultancy Research activities to Pharma companies.
• We do also assist in opting of National/DCP/MRP etc. slots, market search on pivotal scale.