Regulatory Affairs

Regulatory Strategy and Consulting

Ensuring worldwide compliance and providing regulatory guidance

Growing regulatory pressure, threats of litigation over real or perceived side effects, shifting demographic trends in both western and emerging markets, weak pipelines, increasingly heavy competition, skyrocketing expenses and shrinking profit margins – these are just some of the challenges the life science industry is facing today.

To address these issues and minimize their negative impact, organizations are proactively and significantly changing their business models. They are consolidating to leverage economies of scale, capitalize on synergies, and expand their pipeline, while venturing into new markets and new product categories such as biologics. They are also increasing partnerships in areas previously considered proprietary, redefining corporate strategy via diversification versus specialization, deliberately focusing on improving collaborations, and implementing cost reduction programs to grow profit and offset slowing sales growth. And they are increasingly leveraging outsourcing to enable focused excellence on the core business to overcome the above issues.

Our experts offer guidance and strategy to help clients understand and navigate the regulatory challenges that arise during the product development process for generics, biologics and innovator products. Our understanding of the regulatory environment in the emerging markets has enabled us to help our clients develop dossiers specifically for these markets.

We help our clients by:

  • Developing their global submission strategy
  • Advising them on country-specific filing strategies
  • Assisting client interactions with regulatory agencies
  • Preparing and submitting applications that meet regulations and guidelines to regulated and emerging markets, thus minimizing queries and accelerating approval
  • Creating responses to queries from agencies
  • Providing issue-focused regulatory support and gap analysis