Our Services

We mainly provide services under broad categories

RAAJ GPRAC regulatory consulting and intelligence team is comprised of senior Regulatory & GMP experts with extensive experience (More than 25yrs) in product development, preparation of global registration strategies and successful registration of drug substance & drug products with different regulatory authorities worldwide. Our team helps in development of drug products as per global regulatory strategies that enable the most efficient registration pathway(s) and yield a high probability of approval success as per country-specific requirements.

W.e.f. Jan2019 onwards...., we have launched SOFT SKILL training programs like ‘Campus to Corporates [C to C], Train the Trainer[TTT], Problem Solving, Personal Productivity, Good Working Practices[GWP], Feedback & Coaching, Effective Leadership qualities, How to build best Quality Culture? etc..

The portfolio has been developed specifically to help customers expedite the regulatory submission & APPROVAL process and speed time to reach out GLOBAL market in DRUGS, DRUG PRODUCTS, MEDICAL DEVICES[ ISO 13485-QMS], BIOTECH/BIOSIMILARS, VETERINARY, FOODS & NEUTRACEUTICALS ETC..

WE MAINLY PROVIDE SERVICES UNDER BROAD CATEGORIES

Pharma, Biotech, Medical Devices, Neutraceuticals, Herbals registrationsand getting marketing approvals across the Globe

GxP compliance services which includes [GMP, GLP, GCP, GDP, Due diligence, Validations, CSV, Data integrity etc.

Audits & PAI as per country-specific requirements

Regulatory Compilation of all modules CTD-M1, M2, M3, M4, M5 and Global Submissions (pCTD, eCTD, ACTD, NEES formats) and Technical , CMC writings, GMP Validation documentation support as per USFDA, EMA, TGA, MCC, UK-MHRA, SFDA, GCC, CFDA , RoW, Russia & CIS, Indian DCGI & CDSCO and other country-specific requirements.

Structured Product Labeling (SPL) for US. Regulatory Operations; Support in submission management planning and publishing strategy, Assist in Document Level (DLP) and Submission Level Publishing (SLP)

Support industry to harmonize countries wise electronic submissions format, Multi stage review by using effective quality review checklist Structured Product Labeling (SPL); 1) Expertise in conversion of FDA compliant & validated SPL files (XML) 2) NDC Labeler Code / Establishment Registration / GDUFA Identification 3) Drug Labeling (Prescription, OTC and Compounded) 4) Life-cycle management of SPL (version and set id management) 5) SPL validation as per FDA compliant and specification (zero error)

MAA CTD for Europe Submission, South Africa-CTD, Australia-CTD, Kenya & Uganda CTD

ACTD ie. 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,

Existing dossier suitability to new market (Gap analysis and solution)

US-DMF [Type II Drug Master File review and writing in ICH-M4Q format], Active Substance Master File (ASMF)-EU, KDMF (Korean), DMF Type III & Type IV [ Excipients & Packaging materials].

CEP & CoS (Certificate of Suitability to the monographs of European Pharmacopoeia) submission to EDQM

APIMF (WHO), MF (PMDA, Japan) and emerging markets DMF

Product Life cycle Management i.e. Product variation / amendment application - Defining the type of variation (Type I or Type II for EU, PAS, CBE 30 or APR for USA), reviewing technical data, preparation of application and submission to health authority

Query response - Preparation of query response based on Health Authority’s query and timely submission to our client / authority

GMP , GLP, GCP Audits and Compliance, Due Diligence of third parties/vendors

Validations Services ( i.e. Analytical Method Validation, Process Validation, Computer System Validation - CSV as per EU Annex-11, GAMP-5, 21 CFR parts11)

Validation & Qualification of Pharmaceutical Mfg Equipments & Laboratory Instruments [DQ, IQ, OQ, PQ] with complete validation documentation.

Regulatory Compliance Audits, and Mock Audits (PAI)

In House Training and Workshops into RA, QA, GMP, ICH, QbD, Clinical Research, PV, Patent, Validations and related areas, etc.. We can make TAILOR-MADE training programs as per your requirements.

Pharmacovigilance & Medical Writing services

Formulation Development(QbD) , Support for Clinical Trial, BE study and Toxicity Study and Technology and Site transfer etc

Support in Product Development and Technology Transfer, and support in BA/BE studies

GLOBAL REGULATORY AFFAIRS CONSULTANCY SERVICES INCLUDE:

CTD/eCTD

Re-formatting old Dossier/DMF, NTA to CTD/eCTD format

Preparation of DMF/ASMF/ADMF/ CEP or (CoS), Drug Master File (DMF)

Consulting and preparation of all five modules (M-1, M-2, M-3, M-4, M-5) for registration purpose in any country as per latest country specific guidelin

eCTD preparation for USA, Europe, HeathCanada and other country-specific Submission, Writing sections in Module-2, 3, 4 & 5

Technical Support in CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation

SPL

PUBLISHING

Regulatory Services

Drug Firm Establishment Registration with US-FDA (FEI No.)

Drug Listing in SPL format, BULK DRUG Listing

NDC no. and Electronic submission

Regulatory filings of Generics IND/NDA/ANDA/BLA/ANDS etc. to US, Europe, Canada and Row market

Dossier Preparations: Dossier compilation as per ICH Common technical dossier (CTD/eCTD/NeeS) format/ Asian Common Technical Dossier (ACTD) Guidelines / South Africa (MCC-MRF-1) Guidelines/ Brazil ANVISA Guidelines/ Commonwealth of Independent States (CIS) Guidelines/ South East / West Europe Guidelines

Registration of Medical Devices as per USFDA, 510(K), CE marking etc and Nutraceuticals registration as per FSSAI

Critical Review of Dossier and Preparation of GAP Analysis Report

Compilation for open and closed parts

Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR, Manufacturing Formula and Process

Preparation of Summary of Product (SPC/SmPC), Pack Insert, Product rationale

Technical assistance in conducting Bio-availability/ Bio-equivalence Studies,

Clinical Trials studies support

Pre-product registration/ pre-dossier preparation inquiries

Mock Regulatory Audits

cGMP, GLP, GCP Audits

Post Approval activities, Life cycle Management

US FDA eCTD submissions (ANDA,IND,NDA,BLA,AADA,DMF etc.)

Spectrum-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

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

Pay-Per dossier service

For small sized generic companies, we provide Pay per Dossier conversion to create eCTD based submissions.
European Medicines Agency (EMA) eCTD submissions
Spectrum-Raaj GPRAC’s consulting team carries extensive experience in providing consulting for any eCTD submission services made in the context of a Centralized/Decentralized/National/Mutual Recognition application procedure and the subsequent maintenance of the life cycle of the application including:

Initial application

Supplementary information

Variations

Renewals

Follow up measures (FUMs)

Periodic Safety Update Reports (PSURS)

Notifications

MIDDLE EAST GCC (GULF COOPERATION COUNCIL) ECTD SUBMISSIONS

Saudi Food and Drug Authority (SFDA))

Saudi Food and Drug Authority (SFDA) has start accepting dossiers in eCTD format from 03rd Jan 2015.Spectrum-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)

Australia (TGA) eCTD

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). Spectrum-Raaj GPRAC provides submissions in both electronic Common Technical Document (eCTD) and non eCTD (NeeS) formats.

Swissmedic (CH) eCTD

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). Spectrum-Raaj GPRAC provides submissions in both electronic Common Technical Document (eCTD) and non eCTD (NeeS) formats.

In South Africa

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. Spectrum-Raaj GPRAC provides fully regulatory compliant submissions of electronic Common Technical Document (eCTD). Canada (CA-HCSC) eCTD

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)

(Thai-FDA) eCTD

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).