The Pune based Onco Life Sciences has entered into a collaborative agreement with a leading US based consultancy firm SPI USA to train Indian and Asian pharma and biopharma professionals on key international regulatory requirements like facility development, maintenance and process controls.
As per the plans, the partners will offer three to five day open enrolment training programmes for middle and top level management of Indian pharma companies. Plans are to train about 100-150 professionals in a year on areas like GMP, GLP, US FDA and other international regulatory requirements. Experts from USA, including former US FDA professionals will train the professionals. The first open enrolment programme, exclusively for Indian professionals, would be held by the end of this year or in January, next year, Ashish Agarwal, founder and CEO of Onco Life Sciences told Pharmabiz.
"India has about 75 US FDA approved facilities and about 28 facilities are coming up. Considering the stringent requirements of the inspection authorities in terms of facility development, maintenance and process controls, India lags being in terms of qualified trained staff to cater to such large number of high-end projects. The collaboration aims to conduct training seminars with the best possible faculty roping in many ex- USFDA officials, while simulating the real time situations. This training is not only meant to the Middle Management but also to the top management to help them during the planning, implementation and upgradation stages of a project. Besides training, we will also cover various other areas such as project support and bilateral business development" he said.
Apart from this, the partners will offer in-house training for companies with two to three US FDA approved facilities. After the first open enrolment programme, another training session will be offered to the professionals in the region of Hong Kong, Singapore and other Far East countries.
"At present the pharmaceutical companies rely on pharma consultants to get such information and they charge very heavily for that. The collaboration will fill the current vacuum of quality training required for our professionals in the field of international regulatory requirements," he said.
The MoU for collaboration was signed between Dr.Antonio Moreira, executive vice President of SPI USA, Inc. and Ashish Agarwal, Founder & CEO of Onco Life Sciences two weeks ago.
SPI USA, a subsidiary of SPI Portugal, is specialised in the biopharma sectors providing companies with a variety of business and technology consulting services as well as specialized training in various areas of competence. SPI Portugal is mainly engaged in conducting feasibility studies and consultancy to the European Union on various project funding to developing countries.
Onco Life Sciences, started last year, offers consultancy services to life science companies in India. The company has many long term collaborative agreements with leading companies in highly developed markets such as America, Germany, Singapore, South Africa & many more countries. Onco also has been appointed as the Medical associate to Sing Health, Ministry of Health, Singapore.