The Mumbai-based Institute of Pharmaceutical Management (IPM), a training centre offering practical educational programmes for pharmacy students, will soon initiate a new consultancy division to render documentation and dossier filing services for pharmaceutical companies.

The IPM is currently in talks with six pharmaceutical companies to offer services like consultancy in GMP documentation, quality audits, on-site training to industrial professionals, validations and assistance in other regulatory submissions. The institute expects to sign deals with at least three of the companies in the next three months. The consultancy division, which may be floated as a new company under the IPM, will be operational in three months, informed a spokesperson from IPM.

"Through consultancy division, we will be offering almost all the documentation and dossier preparation services required for the pharmaceutical industry for domestic regulatory approval and WHO (World Health Organisation) approval," explained the source. IPM will also provide services to the companies for dossier, document submission with regulatory agencies including the US Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines (EDQM) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The institute is planning either to tie up with a consultancy company or to sign pact with individual freelance consultants to set up the new division. "There is a lot of potential in the market for consultancy firms, as almost all the Indian companies are looking for regulatory approvals in both domestic and the most regulated markets," added the spokesperson. The institute will also offer Drug Master File (DMF) preparation services through the division.

IPM, launched in September 2007, is also planning to launch a new branch for Sunday classes in Mumbai, as the part of its expansion process. The new branch will facilitate regulatory affairs course for 25 pharmacy students in a batch. The educational programmes in Quality Control, Quality Assurance and Regulatory Affairs will be provided in the new branch.

IPM currently offers a two-month crash course on quality control and quality assurance even as the duration of diploma course for regulatory affairs is fixed as six months. The institute has plans to expand the number of courses to a wider segment. However, the source refused to reveal more on it as the plans are currently under consideration and not yet finalised.

IPM has also facilitated a well equipped laboratory, which includes an HPLC system, to provide simulated environment to the current technologies in pharma industry.