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Pharma Tactics Limited

Global IP and Regulatory Consultancy

Dr. Howard Rosenberg

Qualified as a medicinal chemist, having read Chemistry at Oxford, he then completed a medicinal chemistry Ph.D. in the Pharmacy Department of the University of Manchester. His early career includes several years in medicinal chemistry research, firstly synthesising radio-labelled compounds at May and Baker and then 9 years at Beecham Pharmaceuticals researching into several different disease areas before changing direction and moving to Generics [UK] Ltd. in 1986.

At Generics [UK] he was involved not only with Intellectual Property matters on an international scale but in Regulatory Affairs including assisting/visiting API facilities and assessing the corresponding Drug Master Files. He helped to instigate and develop the lobby organisation, now known as the EGA, for the European generics industry.
Throughout all of his time at Generics [UK] IP has been integral to his daily life, advising the companyís lawyers and consultants during numerous litigation cases not only in the UK but further a field, including, USA, Canada, many different European states and Australia.

He has given numerous presentations at various symposia both in UK and abroad covering IP issues, aspects of Active Pharmaceutical Ingredients (APIís) and matters of concern to the generic industry.

As Group IP and API Strategy Director he was responsible for the start up of several distinct and diverse teams covering areas ranging from IP to API synthesis. He then ensured that these different groups were combined into one team managed by him and together they afforded strong scientific input into supporting the company worldwide.
The Patents Group researched patent thickets surrounding all the companyís proposed and existing development programmes.
The Raw Material Sourcing Group investigated sources for new R&D projects, whilst ensuring cGMP manufacture and availability of DMFís and worked with suppliers to ensure registration of their DMFís
The Physical Properties Laboratory investigated the physical forms of APIís, developed IP (patents) and investigated crystalline forms in API and dosage forms.
The API pilot plant in India developed synthetic processes, new crystal forms, obtained IP (patents) and made strategic APIís.

This approach proved very successful and was of great value to the company globally.
Integrated cross-functional teams, in constant harmonious communication, are a powerful way to overcome the many hurdles that occur in the highly competitive pharmaceutical industry.

Pharma Tactics utilises this approach to add value for clients

2 Norrys Close, Barnet, Hertfordshire, EN4 9JY, United Kingdom
Mobile: +44 (0) 7853 018044,
E-mail:- howard@pharmatactics.co.uk