FinnBrit Consulting provides consulting/advisory/trouble-shooting services to the pharmaceutical and related industries in the following areas:

Intellectual property issues relating to formulations:

• Review of draft patents
• Expert witness assistance

Due diligence reviews associated with in-licensing, mergers and acquisitions as follows:

• Viability of CMC programs
• Intellectual property review of formulations
• Suitability of formulations for potential commercial manufacture

Preformulation

Formulation process design, development, scale-up, technical transfer and validation

CMC Development Project Planning including:

• Preclinical
• Micro dosing studies
• Phase I/II
• Phase III/Commercial
• Transition from an R&D organization to include Sales & Marketing

Analytical method development, validation and transfer

Development and manufacture of clinical supplies:

• Micro dosing studies
• Phase I/II studies
• Phase III/Commercial

Excipient development and manufacture

Training:

• Quality by Design
• Preformulation
• Formulation
• Excipients
• CMC Drug Development
• Working with contractors
• Preparing Pharmacopeia monograph proposals

Quality Assurance/cGMP relating to manufacture of both clinical supplies and commercial product

CMC Regulatory documents for:

• Exploratory IND
• IND
• NDA
• ANDA

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Copyright © 2007 FinnBrit Consulting and Lenk Design. All rights reserved.