ADMISSION OPEN FOR GLOBAL RA, QA-QM, CTD-eCCTD....MEDICAL DEVICES COURSES LAUNCHED NEWLY.
Greeting from RAAJ GPRAC PRIVATE LIMITED
Admission open for April 2020
1. Global RA,
3. RA Formulation / API
4. Medical Devices
RAAJ GPRAC & Raaj Pharma eLearning, India incorporated in the year 2009-2010 which is directly benefiting the society with well-planned welfare projects in Life Sciences; Pharma industries. The Management of RAAJ GPRAC, duly incorporated / registered under the relevant Act and based in Thane district, Maharashtra, India.
RAAJ GPRAC & Raaj Pharma eLearning was founded by Rajashri Survase Ojha in 2009-2010 and have been successfully completed 10 years as a Global CONSULTANT, TRAINERS & AUDITORS. We offer services into Pharma, Biotech/Biosimilars, Medical Devices, Neutraceuticals, OTC, Foods, and Veterinary after having 18 years of industrial experience from Sandoz, Ciba-Geigy, Local FDA, Glenmark, GSK-TCS, Novartis, Famycare, Pregna International, Cognizant, Spectrum Pharmatech, Synergy Pharma UAE etc,
We do provide GMP, GLP, GCP , GDP & Global Regulatory services and Pharma TRAININGs across the world through CLASSROOM [CL] Training & DISTANCE learning [DL] education.
The organization profile of RAAJ GPRAC PVT LTD is attached herewith for your ready reference and we can offer a wide range of diversified services as per customer specific requirements: 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. 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, BIOTECH/BIOSIMILARS, VETERINARY, FOODS & NEUTRACEUTICALS ETC..
We mainly provide services under broad categories;
Pharma, [Drug Substance & Drug Products] & Biotech/Biosimilars-
Dossier writing from ACTD[Part I,II,III,IV] and CTD-Module 1 to Module 5 for generics and new drug application [IND, NDA, ANDA, BLA, MAA] Ø Quality Module 3- CMC and Scientific Writing Ø Critical Review of Dossier and Preparation of GAP Analysis Report, Ø Existing dossier suitability to new market (Gap analysis and solution)
API-DMF [Type II , US DMF-Drug Master File review and writing in ICH-M4Q format], Active Substance Master File (ASMF)-EU, KDMF (Korean), CEP & CoS (Certificate of Suitability to the monographs of European Pharmacopoeia) submission to EDQM Ø APIMF (WHO), MF (PMDA, Japan) and emerging markets DMF.
US-DMF Type III & Type IV [ Excipients & Packaging materials].
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 Ø Query response – Preparation of query response based on Health Authority’s query and timely submission to our client / authority
Medical Devices, [QMS as per ISO 13485:2016, Audits, Compliance Inspections, Regulatory filings, 510(k), PMA, SUGAM portal for CDSCO/DCGI submissions, and other country-specific submissions etc for all classes I, II,III as per country-specific requirements.
OTC, Neutraceuticals, Herbals registrations ØAll services start to end.
Regulatory Compilation and Global Submissions (Pctd, Ectd, ACTD, NEES formats) and Technical , CMC, 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. Ø
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) Ø 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) Ø MAA CTD for Europe Submission, South Africa-CTD, Australia-CTD, Kenya & Uganda CTD Ø ACTD ie. ASEAN CTD (Malaysia, Thailand, Philippines, Singapore, Myanmar, Cambodia, Vietnam, Indonesia, Brunei, Laos) Ø Preparation and submission of ANVISA GMP Inspection documents, ANVISA CTD dossiers, Validation package. Ø
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 Ø
GxP compliance services which includes [GMP, GLP, GCP, GDP, Validations, CSV, Data integrity etc. Ø Audits & PAI as per country-specific requirements Ø
GMP , GLP, GCP Audits and Compliance, Due Diligence of third parties/vendors audits.
Validations Services ( i.e. Analytical Method Validation, Process Validation, Computer System Validation – CSV as per EU Annex-11, GAMP-5, 21 CFR parts11) Ø Validation & Qualification of Pharmaceutical Mfg Equipments & Laboratory Instruments [DQ, IQ, OQ, PQ] with complete validation documentation. Ø
Regulatory Compliance Audits, and Mock Audits (PAI) Ø 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. Ø Pharmacovigilance & Medical Writing services Ø
Formulation Development(QbD) , Support for new formulation development, Clinical Trial, BA-BE study and Toxicity Study and Technology and Site transfer etc Ø Support in Product Development and Technology Transfer, and support in BA/BE studies.
Analytical Method Development(QbD/PAT) , Support for new method development, Method validation till Technology Transfer, and support in critical Analysis for Elemental Impurities, EXTRACTABILITY, LEACHABILITY, NMR, XRD, DSC, RAMAN Etc…
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,
- How to build best Quality Culture in Pharma Industry? Etc..
Mission of RAAJ GPRAC is to empower the employees productivity and skills development through relevant education/Skill development and market-focused livelihood programs.
Education and knowledge is very important for a better life. So knowledge is the power and there is no bigger power than the knowledge of power itself.
We do conduct various Technical Sessions, Awareness Session and also Power pack sessions for employee productivity. We are specialized into customized certified Skill Development Programs as per the need of the organization so that manpower will be readily available with the set skills.
Our courses are recognized by Government and NSDC accredited through LSSSDC[Life Science Sectors Skill Development Council]. Our institute is ISO 29990-2010 certified which provides all Advanced knowledge to Fresher’s skilling and Up-skilling for working professionals from Pharma, Biotech, industries and CRO, BPO, KPO etc to BOOST their career. All trained candidates get jobs very easily and prosper into their career very fast. We offer courses as CLASSROOM LEARNING (CL) on Sat/Sunday or through DISTANCE LEARNING (DL) programs.
We have trained more than 10500 candidates till date on various subjects across the GLOBE.
For Course Information, click on below link:
RA API: https://youtu.be/hUKrdtDk6As
RA Formulation: https://youtu.be/jnRpuisYbBc
See what our students have to say about us.
International Student -From Kenya- Catherine Nelson-https://youtu.be/ywMF4buoDWw
Experienced-Komal Testimonial: https://youtu.be/w9ma1CAq1pw
2nd Career Woman-Tanvi Mathur: https://youtu.be/p8X-dEk8AV0
Anuja Deodhar Testimonial: https://youtu.be/qXViZyw8mvQ
Experienced Student-Sujit Godase:https://youtu.be/_qn7Pbfo6Lw
RAAJ GPRAC 10th years successfully journey: https://youtu.be/z9gnrCOCu8M
RAAJ FPRAC 10th Anniversary Celebration: https://youtu.be/PBvTgOw_CUc
Please visit our website at www.raajpharmaelearning.com to know more about us.
We are looking forward for such challenging projects. So you are requested to give us your appointment where we can discuss this in detail.
Thanks and Best regards,
Founder & MD,
RAAJ GPRAC PVT. LTD,
Unit no. 144 & 145 First Floor,
Lodha Boulevard Commercial Premises,
Nashik Highway Road, Majiwada, Thane(West)Pin:400601 ,
M: 9819125208, 9821144706,