Staying ahead of the global regulatory landscape

Regulatory intelligence supports all company activities—from day-to-day compliance to strategic decisions.

A broad view of the regulatory landscape is essential in order to anticipate changes and support the decision-making process.

The regulatory landscape is fluid, requiring regulatory affairs professionals to continuously monitor and identify pertinent regulatory information. The information must be analyzed and interpreted so as to determine its implications to the client organization and any potential impact on the research and development or drug development process.

Regulatory intelligence covers guidance documents, regulations, standards, and international as well as country-specific requirements. When regulatory developments are effectively communicated across relevant departments, companies can respond to changes and their potential impacts more effectively and thereby reduce the risk to their medicinal product development and/or regulatory strategies.

ProductLife Group’s experienced team of regulatory affairs consultants has knowledge and expertise that span all types of products such as traditional pharmaceuticals, generics, cosmetics, vaccines, biologics and biosimilars, and other advanced therapies. Our network of pharmaceutical regulatory consulting experts offers broad strategic knowledge and delivers local coverage in global markets. That coverage enables PLG to apply up-to-date, robust regulatory intelligence to product-development processes and regulatory strategies.

130 countries

ensuring global reach

250

The number of variation packages PLG has prepared and written

200

The number of audits of dossiers PLG has carried out since 2017

100

The number of experts at your disposal for Regulatory Intelligence

A tailored service for clients

The retrieval, collection, and analysis of information are translated—in a single step—into ready-to-consume intelligence for decision makers.

Reports are extremely customizable with regard to sources, topics, and specific areas of interest, providing straightforward impact analysis.

The combination of PLG’s dedicated automated searches together with analysis by our experts ensures timely and relevant tailored reports.

PLG’s solution confers added value

ProductLife Group combines several established sources to generate reports, which are then analyzed and reviewed by subject matter experts for impact analysis of new regulations.

The support PLG provides in the area of global regulatory strategy and the company’s go-to-market approach help safeguard the current portfolio and support business expansion.

The reports enable organizations to anticipate requirements—from both regulatory and business perspectives—and develop well-planned strategies for critical projects such as initial registrations or variation submissions.

Reports may trigger process adaptations in the implementation of new regulatory schedules and timelines, which could in turn affect product supply.

PLG can perform deep-dive analyses to search legislation and analyze changes on key global regulatory topics such as data exclusivity and data protection, eCTD implementation, and serialization.

Customer benefits

  • Cost-effective, ready-to-go intelligence reports
  • Customizable solutions
  • The flexibility to shift the focus of a report or geographic area
  • Responsiveness to a constantly changing regulatory scenario