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.

For your product strategy, in addition to just country regulations, sometimes you may need “big picture” that covers clinical, competitor products, labels, latest regulatory news, safety issues and more.

How should a Biopharma 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 complex 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:

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