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services overview

Fusionlife Solutions has its own Regulatory Affairs (RA) department to offer regulatory support for Pharmaceutical and Biotech companies in the very competitive life sciences field. In Co-operation with our international network of regulatory affairs professionals, we offer diverse services related to Drug Substances and Drug Products in Pharmaceutical and Biotech industry. Fusionlife Solutions’s expertise in regulatory affairs and submissions runs the drug development process: Pre-IND and IND preparation and submissions; pre and post-IND and NDA meetings with the FDA; and preparation and submission of NDA, ANDA and 505(b) (2) NDA. We provide regulatory advice and Solutions, as well as support on your behalf.

Our regulatory services include

Drug Substance Services: DMF, IND, Manufacturing, Import & Exports
Drug Product Services: NDA, ANDA
Pre-IND and Pre-NDA meeting with FDA
Writing and compilation of INDs, NDAs, ANDAs, 505(b) (2) and supplements
eCTD submission
Providing the clearances
Orphan Drug Submissions
Regulatory support for clinical trials, Facility Inspections
CMC (Chemistry, Manufacturing, Control) and Pre-Clinical toxicology
Regulatory agency interaction
Case Report Forms (CRFs)
Product information (SPC, PILs)
RLD Sample Procurement
Pricing and Market Authorisation Approval
Product Life Cycle Management

DRUG MASTER FILE – DMF

Drug Master File (DMF) is a technical documents containing CMC part – chemistry, Manufacturing & control of an Active pharmaceutical ingredient. DMF becomes a part of a registration dossier for finished product registration. Fusionlife Solutions Provides following service in regards to Drug Master File. DMF compilation in CTD Format / Country Specific format.

Open & close part DMF writing
Review of DMF For Submission
Type II (Active Ingredient) DMF Preparation and submission to US FDA.
European Certificate of Suitability (CEP) submission and Preparation.
Canada Submission & Preparation.
PPC can also help you with Analytical Testing – Elemental Analysis, Validations, Stability, etc

CTD – DOSSIERS

Dossier is an integral Part of any registration application for Marketing Authorization. Dossier is submitted to Food & Drug Authority (FDA) or Ministry of health (MOH) or any other equivalent authority along with other required documents. Perfect Pharmaceutical Consultants can help you prepare entire registration file for drug product registration in various countries all over the world. Fusionlife Solutions Provides following service in regards to Dossier Compilation. Dossier Compilation and writing as per CTD Format – Common technical Document

Module 1 – Administrative Information
Module 2 – CTD Overview
Module 3 – Drug & Product Part /CMC
Module 4 – Non Clinical
Module 5 – Clinical

We can help you compile and write entire dossier of specify modules as per your request, we also help companies establish their Document Management and writing system by guiding them draft templates on BMR , COA , MOA , and other technical documents. We customize the same as per company requirement – Good for startup companies or scale up companies

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