How Can Virtual Companies Ensure Compliance?

First and foremost, the buck stops here. With this recognition comes the understanding that there are several crucial elements that require attention, like for example, enough fundraising and proper investment strategies, right-sized resourcing, and ongoing maintenance of infrastructure. Stakeholders have to have clarity about the end point they are attempting to achieve.

Likewise, a clinical study has to be carried out to deliver the necessary data required for a successful filing, and the business must be capable of building and running a compliant supply chain and the supporting infrastructure.

The study has to include a quality system to make sure obligations can be met assertively. This quality system has to be owned by the company and must be overseen by permanent and committed staff who must have a minimum level of technical knowledge and competence to organize procedures to meet a successful conclusion.

Then there is the subject of procurement and contracting. When third parties are accountable for delivering critical regulatory inputs, study or commercial supplies, and key business support, it is crucial to have advanced procurement skills.

Virtual companies may be tempted to use current scientific and technical staff to carry out these activities, and to hand things over to the lawyers at the final stage to put in the boilerplate words and a stamp for signature, but if there was a recipe for underperformance, this will be it.

Procurement is a strategic activity because the services and relationships in the contractor base can signify the difference between success and failure. Costs are considerable and can get out of hand unless the right agreements are made before performing the work.

Remember that CROs and contract manufacturing companies are professional contracting businesses that deserve a professional approach back. To be successful, virtual pharma companies have to understand that strategic procurement is a requisite.

In the end, virtual pharma can be a good or bad option, just as any other type of business model. We've heard and read about companies that have met and matched the challenge, and about many others that have failed miserably.

The stakeholders, investors, payers, providers, regulators, management boards, and staff, are the ones responsible for understanding the risks and opportunities intrinsic to the virtual model within this industry, where safety is critical.

And to help them understand what's at stake they have the pharmaceutical consultant, a neutral party that is ready to guide pharma companies in the right direction.



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