We are a WHO GMP API manufacturing unit . We have 2 USDMFS which we need to file using XML format. Due to lesser requirements we need not feel to invest in buying the software for XML . Sarjen helped us with their software. They come to our office and help us fulfill the USFDA requirements for US DMFS. We are working with them since last five years and are happy with their servces.
Jayesh PatelManaging Director BGP Healthcare Private Limited
We have been using your product and service since 2013 and you have been a great help for our ANDA submissions. KnowledgeNET system is the first and only software we are using to upload, compile and validate our ANDA modules. KnowledgeNET system has a great organization in terms of placing each document to its appropriate position following FDA’s module structure. It is very easy to use. And whenever we have an urgent issue you guys are always there to respond and solve the problem promptly. Thank you!
Wei QuRegulatory Affairs Specialist,AustarPharma, LLC
It’s pleasure working with you guys. One of most important aspects of Sarjen is they are always proactive, irrespective of the challenge Sarjen delivers in time. Final step of Regulatory Submission is always done in tremendous pressure, having Sarjen as publishing partner will take out all the pressure.
Pharma Team Director, Indian Pharmaceutical Company
Sarjen’s Team gives good support to achieve the Time lines for SPL R4 submissions.
P. Kiran Kumar Director, Generic Product Division, Salus Pharma LLC
Sarjen provides excellent service, their KnowledgeNET software is very user friendly, they have highly knowledgeable and professional staff – always eager to help, available 24×7..glad to have them on my side in all my FDA electronic filings..
Raj Desai Director,Excellium Pharmaceutical Inc.
I have been using PvNET for 6 months now and had an overall satisfactory experience. The database has all the features required for establishing an efficient global Pharmacovigilance system. This is a validated system and has also passed through an MHRA audit. We have multiple clients and the system is quiet flexible and allows creation of cases across clients seamlessly. The biggest advantage in working with PvNET has been their excellent support staff, who are more than willing to customize the database to suit our individual needs. The database uses cutting edge technology and has taken inputs from some of the best players in the industry. In the current global scenario while the regulatory requirements become more stringent, the pharmaceutical companies and CRO’s like ours are continuously innovating to meet these requirements keeping the costs low. PvNET is the best bet at the most competitive price to aid us in this challenge.
Dr. Nammi SrinivasLambda Therapeutic Ltd.
Of the handful of options available for internally hosted eCTD solutions, Sarjen System’s KnowledgeNet is a smartly designed interface with an attractive price and the least infrastructure requirements. It is easy to use, easy to understand, and has tremendous appeal for early-stage companies. Sarjen’s personnel were very responsive to our training needs, provided world class technical support and customer service. KnowlegdeNet has also been a time-effective solution for us, allowing us to convert to electronic submissions in under ten days. We are extremely pleased with our partnership with Sarjen Systems, and wish them continued success.
Sree VadlamudiMedline Industries, Inc.