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RAAJ GPRAC MANAGEMENT

RAAJ GPRAC regulatory consulting and intelligence team is comprised of senior Regulatory & GMP experts with extensive experience (More than 36yrs) 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.

We are Client focused, flexible and also cost effective. We strictly adhere to timelines and our data is accurate, reliable and comprehensive and strictly follow ICH-GCP guidelines.

Ms.Rajashri Survase-Ojha

Founder & Director [Raaj GPRAC PVT. LTD]
  • GLOBAL RA & GMP consultant, Lead Auditor ISO 13485-2016, ISO 9001:2015, 21001 : 2018 and trainer
  • Over 36+ years of versatile experience in pharmaceutical industry, starting her career FROM Scientist in R & D, Analytical & Formulation, QA-QM, GLOBAL regulatory Affairs.
  • Expertise in getting marketing approvals of Generics, DRUG SUBSTANCE/DRUG PRODUCTS/ MEDICALDEVICES/ OTC/ Nutraceuticals & FOOD across the Globe. She has Trained more than 45,000 candidates till now on various aspects of GLOBAL
  • Regulatory Affairs, GMP, GLP, GCP, GDP, Country-specific Regulatory Submissions (USFDA, EMA, ROW, ANVISA, WHO, ASEAN, SFDA, CDSCO DCGI & Others)
  • Expertise in ICH, CDER, CFR, Quality Assurance & COMPLIANCE, 21CFR PARTS, GAMP-5, CSV, Clinical Research, Pharmacovigilance, Patents, Pharma Documentation and Pharma Management etc. in Pharma & Biotech industry.
  • Significant experience in Registration, Liasoning and marketing Approvals of pharmaceutical Drug substance and Drug Products.
  • Handled submissions of DMF, KDMF, ASMF, CEP/CoS and
  • CTA/IND/NDA/ANDA/ANDs/MAA to different National & International Health Authorities.
  • Supported Regulatory Audits for USFDA, UK-MHRA, EdQM, ANVISA, TGA, SFDA, TFDA, MHLW/PMDA, WHO and other local Health Authority

AWARDS

Rajashri Ojha has received a token for “Best Individual Contribution” during ANDA filing with zero 483 after successful USFDA Audits

Rajashri Ojha received “Women leadership award in Pharma Coaching” in February 2017

Rajashri Ojha received “Woman in Business Award” on 7th April 2019 from Indo Global SME Chambers at Indore, Hotel Lemon Tree.

RAAJ GPRAC PRIVATE LIMITED has been honored with HEALTH CARE LEADERSHIP AWARDS 2019 by ABP News on 20th November 2019 at Taj Lands End, Bandra, Mumbai

RAAJ GPRAC PVT LTD was nominated for India Pharma Award (under Ancillary Pharma Services) at India Expo Centre Greater Noida in November 2019

Rajashri Ojha won award for "Global Business Women Awards' on the Auspicious occasion of International women's day-8th March 2021. This prestigious awards was received from WASME (World's association of small and medium enterprises)