Case Study

Policy Change Management with Manufacturer

Situation / Issue

A client needed to buy clinical trial products from a manufacturer who do not typically provide products without clinical trial submission, especially when the request is from non-Italian wholesalers.


BAP Pharma Action

Our initial approach to buy clinical quantities was rejected, since the client only had the EudraCT number and the study was not submitted.

BAP Pharma contacted the individual responsible for the distribution of medicinal products to the UK

Due to our Business Manager being fluent in Italian, communication was swift and we were put in touch with the Head of Supply Chain.

Once again our request was rejected, as trial details were required as part of company policy.

At this point, BAP Pharma’s MD got involved with proceedings, urging the manufacturer via email to provide the products. Our business manager kept in regular contact with the Head of Supply Chain and managed to gain agreement that two sampling batches would be provided, with the remainder provided upon approval from the ethical committee.

However, once again there was pushback from the manufacturer, who went on to sell the stock elsewhere.

BAP Pharma then involved the Operations Director, to bring further solutions to the table. We proposed the submission of other written documentation and pushed our supplier to secure the products in advance and hold them at their facility.

Ultimately, through excellent collaboration and not giving up, BAP Pharma was able to influence the manufacturer to accept the written documentation without EC approval and trial details

Outcome / Result

The clinical trial products were secured at our supplier, meaning the client will receive the requested trial quantities without the need for EC approval/trial detail submission and BAP Pharma’s promise is delivered

Required CoA documentation has been provided by the supplier

BAP Pharma Added Value

BAP Pharma managed to change the manufacturers’ existing policy

This was made even more impressive given the difficult circumstances with the Covid-19 pandemic slowing/stopping supply chain

BAP Pharma has gone above and beyond for the client by proactively influencing the manufacturer to change its policy – the goods have now shipped to our supplier without the need of the approval from the EC committee or trial details

BAP was able to source the CoA for the secured batch

BAP delivered its promise and was able to secure the full stock in a significantly lower lead time than expected

BAP differentiated itself from its competitors by being the only company able to influence the manufacturer to change its policy

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