Many small to medium-sized Biotechnology, Pharmaceutical, Medical Device and Diagnostic companies are presented with the challenge of complying with U.S. and international regulatory guidelines without the benefit of experienced QA/QC staff. International BioPharmaceutical Consulting, Inc. was formed to assist organizations in meeting these diverse challenges.

When your highest priority is to quickly build and implement adaptable quality systems, an organization which can provide seasoned professionals offering expertise gained from affiliations with successful companies is invaluable. Past and present clients include manufacturers of external and implantable medical devices and therapeutics such as peptides, carbohydrates, antibodies and genetically altered cell lines for parenteral delivery and small molecules delivered orally.

Consulting with "Virtual" companies and organizations with a preference toward contract manufacturing and testing of early phase clinical and commercial products has resulted in our having direct access to a network of professionals and organizations for production, testing and distribution of products in the United States, Canada, Europe and Asia.

Balancing the benefits of outsourcing with the risk of losing crucial skills is one of the difficult decisions to be made when hiring contractors. Companies that duplicate contractors efforts are significantly diminishing the value of outsourcing.

Although GMP/GLP focuses on process and not outcomes, the sponsor is held directly accountable for the actions of their contractors. IBPC and its associates understand the processes performed by contract manufacturers and laboratories and can evaluate performance on behalf of your company.

IBPC fees are dependent upon the nature of the work and the level of expertise required, but are always competitive. Equity arrangements as partial payment for services may be arranged.