The Bangalore based Dossier Solutions Pvt Ltd will be offering innovative and cost-effective back office support in regulatory affairs and Intellectual Property Rights to pharmaceutical companies It has expertise in dossier compilation and submission to all global markets. The company also offers 'Gap Analysis', which is a meticulous review of the dossier ready-for-submission and support in regulatory due dalliance.

The one year old company is a comprehensive consultancy service provider in the area of regulatory affairs, audits. validation of automation and software supporting the drug development activities at pharmaceutical companies in the country.

Since inception in 2006, it has been able to conclude vendor audits successfully and gap analysis of dossiers. The Common Technical Documents (CTD) dossiers are underway for regulated markets and product development dossiers have been completed for US DA submission. "We have initiated dossier assembly for regulated markets and completed computer software validation at one location while it is in progress at another site." stated Suresh Khanna, founder and managing director, Dossier Solutions and Services who had over two and a half decades of experience in the pharmaceutical industry

The company also has the expertise to conduct comprehensive audits of vendors for active pharmaceutical ingredients APIs), formulations, excipients and packaging according to specified regulatory standards. Such audits, conducted periodically create a transparent working environment between the suppliers and buyers, said Bharathi Ramesh, general manager, regulatory affairs, Dossier Solutions

The company has a team of qualified auditors, lead auditors certified for Food Audits, with experience from several multinational companies (MNCs) who provide their technical expertise to ensure vendor compliance to 1CH, ISO. UK-MHRA, MCC, TGA, in-house or other standards as required. The team is also adept in e-communications and e-submissions and adhere to the growing requirements of T 21CFR11. GAMP V and PICS They also have the exposure to handle software automation, pharmaceutical R&D, production, regulatory practices and audits.

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