Biotech Consultancy

Experienced consultancy

Rapid & measurable results

As a consultancy firm, GRA is fortunate to serve multiple clients across the biotech sector.  By engaging GRA you have the opportunity to implement some of the best practices being currently applied across the biotech industry.

This can allow rapid solutions through application of lessons learned in similar situations.  By avoiding the re-invention of the wheel or by avoiding predictable pitfalls, your organisation doesn’t waste time or money where an organisation’s skillsets or knowledge are insufficient when ready solutions exist.  While knowledge is increasingly and widely disseminated in the form of white papers, articles, webinars, etc., in reality much of the information exists in the collective heads of the consulting associates.

In addition, companies often benefit from a fresh set of eyes – it’s amazing that the amount of value consultants can add based on simple and insights.  Critics contend that some consultants sell “glorified common sense,” but for front-line client employees, it is all too easy to fall into daily routines without a critical eye towards measurement, analysis, and improvement that an experience consultant can bring.

Areas in which GRA provides biotech consultancy services:

Technical

CMC: Process Development, Manufacturing Development, Analytical Development, Control Charting, Tech Transfer, Method validation, process validation

Analytical Development: Development and optimisation of analytical methods & bioassays using DoE approaches

Formulation Development: Development of frozen and lyophilised formulations for biological products

Product Characterization: Development of stratagies and application of orthoganol methods for the characterisation of products and processes

Process Characterization: Building understanding of a production process that ultimately leads to control

Cell & Seed Bank Characterization: Generation of cell and seed banks and their characterization

Regulatory Affairs: Supporting the creation and submission of regulatory dossiers globally

Commercial & Operational

Commercial Support: Providing commercial and operational support to biotech organisations

Biotech Due Diligence: Performing due diligence on biotech companies or helping support companies undergoing due diligence

CMO Management:  Identifying CMOs, initiating contracts and managing the CMO’s

Biotech Licencing: Working with biotech organisations to assist or lead on licencing activities