We are ISO 21001 : 2018 Certified
FORMULATIONS
- Support industry to harmonize countries wise electronic submissions format, Multi stage review by using effective quality review checklist Structured Product Labeling (SPL)
- Expertise in conversion of FDA compliant & validated SPL files (XML)
- NDC Labeller Code / Establishment Registration / GDUFA Identification
- Drug Labeling (Prescription, OTC and Compounded)
- Life-cycle management of SPL (version and set id management)
- SPL validation as per FDA compliant and specification (zero error)
- MAA CTD for Europe Submission, South Africa-CTD, Australia-CTD, Kenya & Uganda CTD
- ACTD i.e. ASEAN CTD (Malaysia, Thailand, Philippines, Singapore, Myanmar, Cambodia, Vietnam, Indonesia, Brunei, Laos)
- Preparation and submission of ANVISA GMP Inspection documents
- ANVISA CTD dossiers
- Validation package.
- Labeling Management - Preparation of draft Labels for Primary and Secondary Packaging Materials, Patient Information Leaflet &SPC.
- Side by Side comparison of Labels in reference to innovator
- Dossier writing from Module 1 to Module 5 for generic and new drug application [IND, NDA, ANDA, BLA]
- Quality Module 3- CMC and Scientific Writing
- Critical Review of Dossier and Preparation of GAP Analysis Report
- Regulatory Compliance Audits, and Mock Audits (PAI)
- Pharmacovigilance & Medical Writing services
