Global PharmaTek 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.Global PharmaTek’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. Global PharmaTek 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.
Global PharmaTek 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.