Regulatory Affairs Solutions

Challenge:

Our client, a small sized U.S.-based biotechnology company developing gene therapy products, needed regulatory consultancy to enter the U.S. and European Union (EU) markets. Additionally, the client lacked in-house EU strategic and operational know-how and did not have a European Economic Area (EEA) established office to apply for and maintain EMA (European Medicines Agency) orphan designation.

Investigational New Drug (IND) research was paper-based and not compliant with electronic common technical document (eCTD) requirements.

Solution:

We leveraged our extensive global regulatory experience to facilitate early engagement with U.S. Food and Drug Administration (FDA) and EMA to receive feedback on clinical, marketing and post-marketing development plans.

Results:

We ensured compliance requirements were met by transferring ownership of IND from investigator to commercial IND and new sponsor within the first 90 days of being awarded the business.

We supported a variety of on-time and of-the-highest-quality submissions resulting in the client securing key product designations less than eight months post-award and achieving key business goals for the year.

Challenge:

Our client, a U.S. biotechnology company seeking to develop a gene-therapy project in Japan, did not have an established local office, including regulatory staff with gene therapy experience, to navigate the very complicated and evolving Japanese regulatory environment.

Solution:

Through our regulatory country-specific expertise in Japan, we delivered a robust strategy and successful PMDA consultation for the gene therapy product.

Results:

Quality and on-time application of three Cartagena Type 1 Use resulted in approval by Ministry Health, Labour, and Welfare within six months of application.

Led the Cartagena Type 1 submission through successful chemistry, manufacturing and controls (CMC) and non-clinical consultation for the first project.

Gained Pharmaceuticals and Medical Devices Agency (PMDA) acceptance of Japan to participate in the global trial without a Phase I trial in Japan.

Challenge:

Our client, a long-term partner since 2013, entrusted us to support the applications for over 50,000 life cycle management submissions for 54 products in 165 countries.

Solution:

Established comprehensive support, including a dedicated Partnership Manager, regulatory submission leads, and PPD RA FLEX, and publishing resources committed to driving continuity and compliance while providing flexibility, quality and cost-predictability across the entire product portfolio.

As an integrated extension of the client’s RA function, we actively engaged in recommending process improvement/implementation, training and monitored established KPIs.

Established an effective executive governance to set vision and provide executive level oversight of strategic, operational and financial performance in accordance with the client’s goals.

Results:

The proof of a successful partnership:

• Significant cost savings as a result of low-cost hubs estimated at ~25%
• Reduced time and cost per unit by up to 60% in first five years of partnership
• Expertly managed task and scope expansions that ensured efficiency, flexibility and cost effectiveness
• Unwavering quality of delivery guaranteed through effective monitoring and oversight

Challenge:

A client with a rapidly growing portfolio was seeking compilation, publishing and submissions of EU/U.K. and ROW in eCTD and NeeS format.

Solution:

To ensure publishing support across different time zones and time regions, we utilized our 24/7 handoff model to deliver on relevant regional regulatory agency guidelines and requirements for electronic and PDF standards.

Provided dedicated support from an experienced core publishing team to oversee timeliness and quality of all publishing.

Results:

Increased productivity enabled by streamlining processes and strong, transparent client partnership.