How-To: Make Regulatory Outsourcing Effective for Pharma, Biotech Industries

A decline in revenues from approved products and rising competition in generics is placing added pressure on resources at all pharmaceutical, biotechnology and medical device companies. Company resources continue to decrease and approval processes and post-approval requirements have become more complex.

Outsourcing can provide a solution and deliver a competitive advantage for companies that lack the resources or expertise to guide a product to approval. Companies, however, need to ensure the outsourcing partner they choose will fit within their current business structure.

According to a white paper recently published by the Cardinal Health Regulatory Sciences team, there are four key factors that can help pharmaceutical and biotech companies become successful in choosing an effective regulatory outsourcing partner.

Know When to Consider Outsourcing

Shortage of employees is one of the primary reasons companies choose to outsource during the regulatory approval process. Additionally, a company may have more products in development than internal staff is available to guide to approval in a timely manner.

External staff can alleviate both of these issues by handling routine regulatory maintenance so internal staff can focus their attention on high-priority development programs.

Partnering with regulatory experts can also save valuable time and unnecessary work; especially if there have been recent changes to regulations. By using such experts on an “as-needed” basis, costs can be minimized rather than keeping individuals on staff long-term.

Determine What Functions are Best Outsourced

While entire pharmaceutical, biologic, or device development processes can be outsourced, companies generally outsource either discrete processes, such as clinical trials, or those that require a high level of expertise, such as regulatory affair processes or the formulation of development processes.

Both consultative and tactical functions are good candidates for outsourcing, according to the report. From a consultative viewpoint, the right partner can advise a company on strategic and specific information that regulatory agencies will be expecting to see in a submission.

Tactical functions, such as CMC and medical writing, are also prime candidates for outsourcing. Regulatory documents and scientific communications require a high level of precision and adherence to format, which may be best left to an experienced partner.

 Learn How Your Company Can Benefit

Outsourcing provides companies with a plethora of benefits from flexibility, on-demand capacity and anticipating and preventing obstacles.

In times of need, a company can augment or add a new team when work levels are high. This helps keep budgets in line but also allows companies to bring in the exact skills required for a specific project at any given time.

In addition to augmenting staff, outsourcing also allows companies to add to their capacity when products require resources unexpectedly. Regulatory consultants can often step in and resolve unforeseen outcomes or late-breaking changes that may affect a product’s development cycle.

Regulatory scientists understand the entire research and development continuum, which allows them to build the required components into research so the study design, resulting data and documentation are appropriate prior to submission. They can also review nonclinical, clinical, CMC and compliance documents and use their expertise to anticipate any new requirements that may pose challenges.

Select the Right Partner

The right strategic partner will work with a company to ensure that the regulatory product is brought in at the appropriate time and work towards the company’s goal. By starting early, discussing the process and setting checkpoints, both the company and the partner can establish a long-term relationship and smooth collaboration.

It is important to ask questions about a partner’s background, track record and experience. A partner who lacks the expertise required for approval or who fails to deliver on time can result in a costly operation. The right partner should also have experience in the entire development process to foresee and prevent any issues from arising.

Ideally, companies should seek a partner who can become an extension of their organization.