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OUR SERVICES

Pharmaceutical Technologies – Project specific consultancy

* Sourcing specific technologies to match the pharmacokinetic requirements of the molecule

* Identifying and progressing fast track routes from early development to regulatory submission

* Help in designing appropriate dose forms and analytical methods at various stages of development

* Integrating CMC with accompanying disciplines such as preclinical and clinical development activities

* Recommending either client-based or outsourced project work

CMC regulatory consultancy

* Dossier gap analysis

* Representation at regulatory agencies

* Writing specific sections of the Common Technical Document relating to CMC activities

Contract Business Development

* Targeting niche business opportunities in the EU, USA and Japan particularly

* Preparing business plans and venture capital proposals

* Progressing deals to final Contract status with clients

* Preparing associated Technical Agreements

* Arranging strategic alliances

Outsource Management

* Identifying suitable outsource partners

* Project management

* Achieve quality, on-schedule and on-budget results

Interim Management

* Working in tandem with our associate agencies to provide a world-class, skilled, scientific management service

* Seamless management activities during temporary absences, for example due to maternity / paternity leave, long-term sickness or between permanent job-fills

* Developing and implementing solutions to client's management issues

* Enhancing client's management skills portfolio

Search & Select

* Working with respected pharmaceutical search and selection organisations to recruit the right niche employees at senior levels

* Wide net-cast and specific contacts in the Pharmaceutical Sciences particularly

* Candidate long-list identification by research, role brief preparation or review, short-list creation, internal / external candidate interviewing and provision of reports for final selection by the client

Conference and Training Course Organisation

* Working with respected conference administration organisations

* Venue selection

* Potential delegate identification and contact via mailings, e-mailings, verbal contact etc.

* Session chairing

* Feedback reports

The current range of consultancy services has been deliberately focussed on areas of pharmaceutical Chemistry, Manufacturing and Control (CMC). Enveloped within this field lies specific expertise in formulation design and development, both at the preclinical and early clinical stages of the drug development life-cycle, in order to move projects through to Proof of Concept studies as quickly and cost-effectively as possible. Allied to the formulation design, analytical method development and validation, together with the development of Quality Control and Stability specifications, are also essential specialisms of this consultancy service.


Following the early exploratory clinical phases, successful lead candidates can then be more accurately formulated for later Phase II / III clinical trials, in the knowledge of promising pharmacokinetic and toxicity data, the objective being to design the final marketed formulation and pack for the selected launch markets in an appropriate manner. White Rose Consulting can manage such CMC activities either with the client directly or via the most appropriate Contract (Pharmaceutical) Research Organisation.


Since this consultancy can claim commercial skills to match its scientific talents, a business development service is offered mainly to Contract (Pharmaceutical) Research Organisations and novel drug delivery companies, who either do not possess or have insufficient resources to achieve their ambitious selling targets. White Rose Consulting has almost nine years of sales and marketing experience to offer our clients, about half of which relates directly to selling drug development services into the Asia Pacific region.


In summary, at the heart of this consultancy lies the ability to add value to the selected project, whether measured by scientific skills, project management from start to finish, or resulting commercial benefit.


Please read further for details of these and other allied services which this consultancy can bring to you.

 
KEY SKILLS
 

Unique ability to successfully lead and motivate large teams of scientific experts/specialists, to achieve project deadlines.

Excellent commercial awareness of business development needs, leading to maximum utilisation of direct and indirect resources.

Entrepreneurial approach to novel pharmaceutical technologies, targeted towards in-house applications, and drawn from a large portfolio of external scientific contacts and co-operations worldwide.

Efficient and successful operation of multi-million pound revenue and capital expenditure budgets.

Practice modern management approaches to maximise principles of multitasking and prioritisation in an environment of urgency and achievement.

   
USEFUL LINKS
 


Some EU Regulatory Agency links
www.emea.eu.int, www.mhra.gov.uk

US Regulatory Agency link www.fda.gov

Some major Contract Research/Manufacturing Organisations www.quintiles.com, www.r5pharma.com, www.covance.com, www.bio-images.co.uk, www.nextpharma.com

Interim Management Links www.peopleinhealth.com, www.hartengroup.co.uk

Search & Select links www.garthheron.com, www.andersenpiquet.com

Conference & Training Course Organisation links www.informa.com, www.pti-international.com, www.ecec.co.uk

CMC quality assurance consultancy contact Zelda Carr at CQC Limited zelda@cqc-ltd.com

 

 
     
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White Rose Consulting Ltd, Registered in England, UK No. 5125148.

Registered office: 3 Leary Crescent, Newport Pagnell, Buckinghamshire, MK16 9GA, United Kingdom