We are ISO 21001 : 2018 Certified
Global Regulatory Affairs Services
Entering into the international markets of EU, USA and other emerging ones like African subcontinent, requires a detailed understanding of complicated regulatory requirements. At RAAJ, we ease the process of seeking swift approval for your products by defining country specific regulatory strategies right at the early stage of product development, eliminating potential hurdles and ironing out any kinks en-route to a successful product launch. As a Global Regulatory Affairs Consultants, we provide scientifically-based therapeutically-focused regulatory services from strategy to execution. Also, Technical review of change controls. Gap analysis of the variation/supplement submission strategy and suggestions are smoothly executed at Global Level.
Country Specific Services are as follows.
A. US-FDA (e-CTD Submissions ANDA, IND, NDA, BLA, AADA, DMF etc)
Raaj GPRAC offers the following eCTD submission services to ensure US FDA acceptable eCTD enabled submissions. Granularity and life cycle management of documents
- US FDA specific document formatting and publishing
- Dossier writing from Module 1 to Module 5 for generic and new drug application [IND, NDA, ANDA, BLA]
- Navigation Aid Management including the table of contents and hyperlinks
- Dossier assembly and compilation in eCTD format
- Paper to Electronic document conversion to provided searchable text-based documents as required by US FDA
- Electronic Submissions gateway setup and administration
B. Saudi Food and Drug Authority (SFDA)
Saudi Food and Drug Authority (SFDA) has start accepting dossiers in eCTD format from 03rd Jan 2015.Raaj GPRAC with its experienced team offers eCTD submission Services for maintenance of the lifecycle of the following application for Middle East GCC (Gulf Cooperation Council) countries:
- New Marketing Authorization
- Renewal of Marketing Authorization
- Variation Type 1
- Variation Type 2
- Responses to Questions
- Periodic Safety Update Report (PSURs)
C. Australia, TGA (Therapeutic Goods Administration)
The Drug Regulatory Authority of Australia, TGA (Therapeutic Goods Administration) has initiated the implementation of electronic application (eCTD) software which is required for validation & review of electronic applications (eCTD) for the approval of registered medicines (new chemical entity, major variations to a prescription medicine & generic medicine) on to the Australian Register of Therapeutic Goods (ARTG).Raaj GPRAC provides submissions in both electronic Common Technical Document (eCTD) and non eCTD (NeeS) formats.
D. South Africa, Medicines Control Council (MCC)
In South Africa, Medicines Control Council (MCC) initiated acceptance of eCTD submission with ZA (South Africa) Module 1 Specification, version 1.0 and Validation Criteria version 1.0. Raaj GPRAC provides fully regulatory compliant submissions of electronic Common Technical Document (eCTD). Canada (CA-HCSC) eCTD
E. CANADA-HCSC
Raaj GPRAC provides eCTD submission Services for maintenance of the lifecycle of the following application for Canada (CA-HCSC)
- New Drug Submission (NDS)
- Supplement to a New Drug Submission (SNDS)
- Supplement to a New Drug Submission – Confirmatory (SNDS-C)
- Abbreviated New Drug Submission (ANDS)
- Supplement to Abbreviated New Drug Submission (SANDS)
F. Thai FDA (Thailand)
Regulatory Affairs in a Pharmaceutical industry,
- Thai FDA (Thailand) had started accepting eCTD submission from May 2015. Authority has mandated eCTD Submission for New Chemical Entity, New Drug, New Biological,
- Biological and optional for Generic and New Generic in 2016.
- In 2017 eCTD submission will be mandate for all submission.
- Current Thai-FDA Module 1 Specification, version 1.0 and Validation Criteria version 1.0. is required by Thai FDA (Thailand).