Dr. David Longridge, Preclinical Advisor of MedPharm, has a renowned expertise for providing tailored preclinical development packages specifically designed for the small start-up pharmaceutical, biotechnology and drug delivery company in order to support "Proof of Principle in man" up to "Product Registration".

Preclinical packages are drawn from the formulation, analytical, delivery system and preclinical expertise within the core-business. Minimalists ones can be provided for Proof of Principle in man (Phase I).

MedPharm offers the following preclinical services to clients:

Strategic planning

• Establish focussed and attainable goals for all preclinical aspects of your development programme
• Write strategic and tactical preclinical development plans to incorporate within your overall Product development plan
• Prepare presentations of such plans to your senior management, potential investors and Regulatory authorities

Preclinical efficacy and safety testing

• Identify and write appropriate efficacy and safety testing strategies
• Identify major academic/commercial service providers
  Prepare, review and edit efficacy/safety test protocols
• Write, review and edit preclinical data package(s) and report(s)

Safety testing (biocompatibility) - medical devices

• Identify current safety database on materials intended for use in your medical device
• Perform risk analysis with respect to intended human exposure
• Identity commercial safety testing providers
• Prepare, review and edit test protocols
• Place and manage biocompatibility test programme
• Write, review and edit data package(s) and report(s)

Project Management

• Identify and integrate preclinical development programme into your fully integrated Product development plan
• Manage academic/commercial service providers
• Manage smaller subcontractors in support of service providers
• Manage timelines and allocated budget

Regulatory Affairs

• Prepare appropriate sections for your regulatory documents: IND, CTX, PLA, NDA.
• Represent preclinical aspects of your Product development to appropriate Regulatory Authorities

Quality Systems and Assurance

• Prepare Quality policies in compliance with GLP
• Write Standard Operating Procedures
• Aid with the implementation of Corporate Quality Systems

Business Development

• Prepare and present technical aspects of your Projects to the business community e.g. prospective partners and potential investor

MedPharm offers a comprehensive clinical trials service in dermatology in both patients and healthy volunteers. MedPharm has access to the significant resources of Kings College London including the St. John's Institute of Dermatology. The Institute is located within the Guy's and St. Thomas 's NHS Foundation Trust and records over 60,000 patient episodes per annum, with major secondary and tertiary referral activity. Specialist services include autoimmune and inflammatory skin diseases, psoriasis, cutaneous lymphoma and melanoma together with the National Epidermolysis Bullosa Centre.

 Dr. Richard Groves FRCP, Head of Clinical Immunodermatology at St. John's , manages MedPharm's Clinical Research in Dermatology. He is an internationally recognized expert on inflammatory diseases of the skin. Dr. Groves has presented many invited lectures, published over 40 original papers, and has contributed to several books. He is the immediate past Editor of the Journal of Dermatological Treatment and is on the Editorial Board of the British Journal of Dermatology. Dr. Groves is available for consultation on drug development (link to drug targets) and clinical study design to all MedPharm's clients

 MedPharm has access to clinics and state of the art investigative laboratories. MedPharms's experience spans a diverse range of work, from routine European trials to specialist studies in cutaneous research and volunteer studies in academic units. Diseases investigated include:

• Acne
• Psoriasis
• Eczema/dermatitis
• Autoimmune skin disease
• Skin Infections
• Basal Cell Carcinoma
• Premalignant skin lesions
• Hair Loss
• Herpes Zoster

MedPharm offers the following clinical services to clients:

• Study Design
• Protocol writing and/or review
• Compilation of Investigator's Brochures
• Case Report Form design and/or review
• Ethics submissions
• CRO selection
• Study management
• Monitoring
• Arrangement of data management and statistics
• Project management
• Final Study Report writing and/or review
• Writing of safety summaries and expert reports
• ICH SOP writing and/or review

The above can be supplied as a package or stand-alone services, to suit your needs.