I am very grateful to have got the ppportunity to attend Medical Devices Course with Raaj GPRAC team. My expericence of joining Medical Device Regulations Course wirh Raaj GPRAC is very good. All the topics were well explained with real examples from Medical Device industry. All the trainers made the sessions very interactive by asking questions in between and discussing cse studies. The teaching methodology and study material provided were excellent. Mrs. Rajashri Ojha (Founder of RAAJ GPRAC) is a very knowledgeable, humble, passionate person and an expert in her field; she is also a very good guid and mentor, teaching from personal experience to show you the way. I thank Mrs. Rajashri Ojha and her Team and convey my best wishes to all of them/

Nupur Pitkar

-Director, SAP function at S.H. Pitkar Orthotools Pvt.Ltd

“Rajashri, is sincere and hardworking. She is knowledgably in her subject and is thorough in her work output. She has good analytical and communication skills. Her personality makes it easy for her to connect and work with people at all levels. She will be an asset to any company she works for.”

Meghana Inamdar

-General Counsel, India & APAC Cluster Countries, Sandoz PVT LTD

I am greatful to Rajashri for organizing such type of workshop for industrial people. I could attend few sessions and I liked it very much. It was pleasure to be with you all. You have very good trainers. Wish you all the BEST!

Kim Stranick

It is with great pride and pleasure that I recommend my friend (Ms. Rajashri) as a great human being and team player. I have known her for over 10 years now. She has a very cheerful disposition and I have seen her handle even the most stressful of situations with a smile on her face. Her positive attitude, enthusiasm and vivacious nature have always made a great difference to everybody around her.

Dr. Nandkumar Chodankar

Rajashri is a thorough professional with a clear focus on results.She is detail orientented but at the same time does not lose thesight of the big picture. She knows how to get things done. She iscalm and composed. She is a nice person to work with.

Rajesh Parab

It’s my pleasure to provide recommendation to Rajashri as we worked closely in Sandoz and we know each other since 14 years.She is excellent in communication, hard worker and consistently exceeded her excellence in pharma regulatory field. On a personal level, she’s charismatic and well-spoken, both qualities that have served her well in pharma industry. Since she carried a leadership quality and after pursuing her execellence in Regulatary field she become a well known persoqualityin all phrama industries in India as well as abroad.She is very open , expressive and kind person. Due her nature she imbibe great value in her buisness. I wish her a good progress and sucess ahead. Once again wish her a Best luck for serving pharma industry.Keep it up!!!!

Abhijeet Khompi

I have had several interactions with Rajashri and am particularlyamazed by her dedication and hard working attitude. Her attention to details is something to look up to and her friendly nature enables having a comfort zone while coordinating with her.

Amol Gaikwad

Raaj GPRAC is a professional institute in the field of Regulatory andcompliance.Rajashri mam really helps students to upgradeknowledge and grow professionally.

Asheesh Bhimsaria

I know Rajashri when she was working in Sandoz, she is very nicecolleague to work with. She is a good team player and has depth inher subject knowledge. I appreciate her cooperation with crossfunction teams.

Ashwin Desmukh

Rajashri is self motivated employee. She takes initiative on her own to implement new system and processes. She was managing documentation archival and retrival under my supervision at Novartis Eneterprise Pvt. Ltd. She was also responsible for creating dossiers for several market. I'm pleased to recommend her for a suitable role in Regulatory affairs area.

Chandrashekar Nimkar

he is among the very senior persons which I know in Pharma. Has profound knowledge and depth of understanding about Regulatory system ,GMP and Audits. And very good trainer. And down to earth personality.

Chetan Doshi

Rajashri is a very organized person and had good knowledge on documentation required for registration/regulatory purposes. She was meticulous in the job she performed and always strived to learn more and improve herself. She was always helpful and co-operative towards her co workers.

Madhavi Desai

Rajashri is focused person very open to learning and so she takes profit of any experience. She has very good understanding of the organization and interference between line functions in project development. Encourages others through own enthusiasm. Maintains positive attitude during changes. Pushed herself and others. Takes responsibilities for own actions. Fully support and implements decisions. Is 100% committed to achieve agreed upon targets. Does not give up, especially in the face of adversity. Rajashri builds trust among team members as someone with integrity. Rajashri is a team player, she is transparent and communicate openly on regular basis (this allow me to be up to date on any topic under her responsibility). She asks questions to clarify situations. Readily helps colleagues with work issues. Collaborates with colleagues. It is a real pleasure to work with Rajashri.

Mallika Tushakiran

Rajashri is a highly intelligent and hard-working, and specialist for Regulatory and Compliance. She has outstanding working relations with her fellow in pharmaceutical industry and developedimportant contacts within her areas of industry. I recommend her highly professional and skilled person.

Olivier Moreau

Rajashri is a nice person and it was good to work with her. She was helpfull and good in her job. I wish her the best in her activities.

Pradeep Singh

I have known Rajashree for nearly a decade and have to salute her passion and hard work in Regulatory Affairs area that Raaj Global has emerged as one of the leading training organization in the country. Rajashree is extremely dedicated to her profession and i am infact honoured and previlaged to have been associated with her on various occassions and have participated as a guest speaker in a number of training programmes. She is always there to help and her eagerness to help and training skills has helped many organizations and helped a number of pharmacists to start a glorious career. Kudos to Rajashree and a big thanks to her for all the support that she has provided.

Prasad Deshpande

Rajashri is a real asset to any company. She is really good at what she does and very co operative and helpful within team environment. I remember her devotion to work when she was working in HDC.

Santosh Kashyap

Rajashri Survase Ojha has 17 years experience and presently working with Novartis Healthcare Pvt.Ltd as Manager-Global Regulatory Affairs,CMC since June2007. She is B.Pharm and Advance Diploma in Pharmaceutical QA & QM. She also has PG Diploma in Patents Law and Test Procedures. She is based in Mumbai. She has experience in Analytical development, Formulation, Technical documentation, ANDA/ANDS submission, Clinical submission & Regulatory Affairs-CMC. She has hands on experience of US- ANDA filing (Generics) and CTD dossiers for various European and Row countries. She is well versed and having hands on experience with CMC section i.e.Quality module-3 with QOS along with other CTD modules. She can handle US(Generics), with IND/NDA/ANDA submissions, EU and Row markets as per different regulatory requirements, in CTD formats, ACTD/ACTR (Asian countries)etc. She has all kind of Guidances, Procedures, Checklists available with her.She has awareness of requirements of Asian countries(ACTD/ACTR), Latam and Mexico and awareness of ICH guidelines, USFDA, EMea, Indian requirements of local FDA, licensing etc... She has visited twice to GSK-UK for international assignments in TCS. Attended Documentation workshop and trained on IMMS (International Module Management System). Successfully completed transition process between GSK and TCS within short period of time. Fully settled the Dept.with 12 Document Specialist. She also has visited twice to NCH-Nyon-Switzeland. She has attended training on Gema(Global Electronic Marketing Authorization) and Global regulatory workshops. She has Organized many trainings and workshops till date on CTD/eCTD, 21 CFR parts,IND/NDA/ANDA submissions, Gema, Novstyle, IRDDS, CMC & other Regulatory requirements of documentation required for submisssions in various countries. She is reporting to Global Head- GRA-CMC. She has one Asst. Mgr+2 CMC-Document Writers in her team.

Shailesh Kodolikar

“Rajashri very well understands business requirements and puts in her very best to support business as far as Regulatory issues are concerned. I have known her to be very dedicated and hardworking person.”

Sharmistha Pal