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Regulatory Intelligence

Regulatory requirements change daily. While some countries provide these well on their websites, most countries getting updated or accurate information is a challenge. Adding to that, language translations involved and in some countries multiple government entities handle different regulations and those are not centralized.

For Consumer Healthcare companies, requirements are diverse and lot of variation between countries. On top of this, some countries classify products in different categories (for instance, a cosmetic in one country may be treated as an OTC in another country)

How should a Consumer company prepare for upcoming changes, and how do you ensure timely review of guidelines? How can the impact of the changes be assessed? How can you determine which stakeholders to involve and in what way? How do you ensure a right and optimal, yet efficient process, from start to end? One of the answers to this is “Regulatory Intelligence.”

Our Role:

MakroCare helps navigate increasingly diverse and broad global regulatory requirements while refining and regulating processes across functions and geographies. Our regulatory experts offer insights on regulatory strategy to support your product and country goals. Our proprietary database enables us to deliver up-to-date regulatory requirements to support product development and registration strategies globally.

MakroCare can help your business with the below global regulatory intelligence consulting services:

  • Bullet Provides Intelligence on end to end regulatory requirements with a clear understanding on global and regional regulatory requirements
  • Bullet Share Reports and Insights on current trends
  • Bullet Formulate regulatory submission strategy considering internal data and up-to-date/future regulations
  • Bullet Prepare impact analysis reports for your product portfolio to help organizations understand impact of changing regulations
  • Bullet Perform competitive product gap analysis to provide intelligence that supports product benchmarking

Why MakroCare?

MakoCare brings together a unique combination of an Intelligent, reliable and deep regulatory content database covering 120+ countries regulatory requirements with experienced in-house team to support global regulatory intelligence reporting. Our teams bring you unparalleled data based advice, evidence-based consulting, and strategic approach across the biopharmaceutical regulatory life cycle.

The First Step

Let's talk about how MakroCare can help you