Trillyum offers specialised GMP consulting and Advisory services to the pharmaceutical and healthcare industries including medical devices ..As a leading GMP consultancy, we provide these consulting services to those industries subject to Schedule M ,PIC/S, European (EMA), US (FDA), PMDA Japan and Australian (TGA), drug and medical device regulations, such as the US FDA 21 CFR Part 820, and the ISO 13485 Quality Management System for Medical Devices and ISO 14971 Risk Management for Medical Devices.

Direct a 100 % subsidiary of Eisai Co. Japan, an 8.5 Bill USD company with headquarters in Tokyo. The subsidiary in India is an integrated complex of API Process research, API manufacturing and formulation manufacturing for global markets including Japan, US, EU, etc. Joined the company as Founding Member in May 2007 to create a fourth knowledge creation center at India. Contribute in company’s mission by developing new business through introduction of new service lines and refinement of existing offerings, based on information gathered via primary and secondary research.Nurture set-ups and transform them into profitable ventures; garnered buy-in from stakeholders to support major initiatives, while at the same-time, build credibility and deliver on customer confidence.Participate in high level operational initiatives, including manufacturing excellence, process reengineering, turnaround management, and reorganization. As an innovative marketer use instincts, insight, judgment, and timing to succeed on tough deal.Leading teams towards the achievement of organizational goals and industry best practices.

Managing Director of Eisai Pharmatechnology and Manufacturing ,India

Heading Eisai at Vizag ,India , an integrated complex of Research and Manufacturing of APIs and Finished dosages for supply to global Eisai network.

•Commanded state-of-the-art facility for manufacturing a 4 Billion capacity tablets, HG capsule / Soft Gel capsule facility, and sterile API / Dosage form facility .•Established & commissioned a new sterile APIs / dosage forms facility for global markets including state of the art robotics use in manufacturing.

•Headed the total operations management and regulatory compliance of 4 pharmaceutical formulation manufacturing facilities of Sterile and non-Sterile Cephalosporins, Anti TB dosage forms, Herbal preparations at Mandideep near Bhopal, and the multi-product facility at Goa.•Earned success in getting the facilities for Sterile Cephalosporins approved by US FDA and MHRA for the first time in India in 2003.•Built an online inspection system for detecting glass contamination in powder filled vials for the first time in the world using X Ray technology

I was instrumental as a leader in commissioning and regulatory approval for the oral and sterile formulation at Bhopal and Oral solid dose facility at Goa .

Monitored operations of plant manufacturing 400 thousand sterile vials and 60 thousand pre-filled syringes per-day. Strategized and standardized systems and procedures for registration of products in US and European markets including the guidance for regulatory requirements.

Project and Manufacturing head of Aseptic processing facility

Commissioning / Qualification and Validation of new Oral solid dose facility

Team leader for the Aseptic processing manufacturing

Team member of Aseptic processing manufacturing