Services Provided

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


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


  • 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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All information published throughout is intended for information only, and does not contain any warranties, implied or otherwise.

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

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