JW Cross Consulting
7508 Milway Drive
Alexandria, VA 22306-2525

Phone: 703 768-4455
FAX: 815 550-4412
Website: http://mysite.verizon.net/vze3gfjm/consult/

Dear Sir or Madam:

I invite you to consider JW Cross Consulting for your requirements in biotechnology, biopharmaceuticals and regulatory affairs.

Regulatory Experience:

• Planning and execution of CTD regulatory submissions in a team effort: Clinical / Preclinical / CMC documentation for IND / CTA / NDA / BLA applications.
• Direct interactions with FDA: Pre-IND teleconferences, informal telephone queries, FOI requests, served as a US Agent for foreign concerns.
• Inspections on-site: cGLP and cGMP audits under FDA or EMEA regulations.
• Evaluation and editing of pre-clinical and clinical protocols, preparation of investigators' brochures.
• Preparing reports interpreting FDA and country-by-country EU regulations for advanced cellular and gene therapies, ethics committees, packaging and other specific issues.
• Managing preparation and translation of package insert materials for all EU languages.
• Preparation of TSE risk analysis dossiers, and TSE and biosafety investigations of the sources and regulatory compliance of raw materials for biologicals manufacture.

Program Management Experience:

• Managed research grant programs at a private biomedical research foundation and NSF.
• Recommended over $25 million in grants annually at NSF.
• Negotiated terms and agreements for grants and intellectual property for a private foundation.
• Planned, secured funding, executed and reported successful biotechnology R&D projects and studies.
• Initiated, negotiated and managed contracts with consultants and cooperators.

A full resume and my fee schedule are available on request.

Best wishes,

John W. Cross, Ph.D.