Our Services - Greetings from RAAJ GPRAC Pvt Ltd & RAAJ Pharma E-Learning

Namaste!!

Greetings of the day!!!!

I’m Mrs. Rajashri Ojha and I’m Founder & Technical Director of RAAJ GPRAC & Raaj Pharma E-Learning. Our companies work in all areas with SME [Subject matter Expertise]… so I believe we could both benefit from cooperating with one another.?

For the last?34 years?we have been?Global Consultants, Trainers and Auditors in Pharmaceutical, Biotech / Biosimilars,?Nutraceutical, Medical Devices, Cosmetics, Food and Veterinary Industries.

We would like to introduce ourselves as one of the leading Technical Services providing organization offering our services for in the field of Global Regulatory Approvals from USFDA, EMA, EdQM, Health Canada, TGA-Australia, LATAM, ASEAN, RIC+, Japan, GCC, CDSCO, MENA,? etc...

?We are?GxP [GMP, GLP, GCP, GDP]?Compliance Auditors & Trainers and trained professionals more than?45,000?till date in different areas of?Pharmaceuticals, Biotech, Medical Devices, Nutraceuticals/Foods & Veterinary.

?INDIAN-Regulatory approvals?(CDSCO/DCGI),?BIS-(ISI marks),?Product Testing,?Product Certifications?(CE marking) and?Management System Certifications?(ISO 13485-2016, ISO 9001-2015, ISO 14000, ISO 45000, ISO/IEC-17025, FSSC), MDSAP?across the globe.?

?We?are a one stop solution for?INTERNATIONAL & INDIAN Regulatory Services under CDSCO,?whether it is licensing or NOCs.

?We offer: IND, NDA, ANDA, MAA, BLA, 510(K), PMA, SUBMISSIONS,?Regulatory Services for CDSCO/DCGI for grant of?Approval?of Manufacturing & Test License. We also support the DMF. CEP, ASMF, Technical files etc as per country-specific?requirements like CTD/eCTD/ NEES/ACTD.

?Services in following areas as per Indian CDSCO and Indian MDR-2017:

?????Test License for Investigation or new device registration

?????Manufacturing License, NOC

?????Import license and Importer registration

?????Wholesale/Trading License

?????Technical Documentation and implementation as per?Medical Device Rules 2017 (India), EU MDR, MDD to MDR Implementation, MDSAP

?To explore the full spectrum of our offerings, please find our company brochure for your reference.

If you are interested in the above services, please send us the email mentioning the service(s) you required, which will allow us to provide you with the best proposal along with a road map for the chosen services.

?Please find the link below for your reference.

Company Website: -?https://raajgprac.com/

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?https://raajpharmaelearning.com/

?Looking forward to have long term association with your organization

?Dhanyawad!

?Best regards,

Rajashri Survase-Ojha Founder & Director GxP, Global RA Consultant, Auditor, Trainer Lead Auditor ISO;13485-2016, ISO;9001-2015, ISO/IEC-17025-2017, FSSC-22000,V-6