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Regulatory Strategy

Being compliant with ever changing global pharmaceutical regulatory requirements is challenging for BioPharma product approvals. To ensure consistency and to stay compliant with regulatory updates, your products need a well-formulated regulatory strategy to maximize the opportunity to achieve product goals.

Our Global Regulatory experts help you frame Regulatory strategies for end to end product development to commercialization, addressing all regulatory requirements taking your product into context. With comprehensive and vast expertise gained from our successful management of global regulatory projects, we help you achieve regulatory approvals and market access for your product much faster while minimizing risk at every step.

What We Do?

  • Bullet Keep up to date with global regulations in 120+ countries
  • Bullet Interpret regulations and guidelines
  • Bullet Provide optimal submission strategies
  • Bullet Advisory support and health agency discussions
  • Bullet Provide regulatory information for product life cycle planning
  • Bullet Rx to OTC switches
  • Bullet Support borderline products with regulatory strategy

Why MakroCare?

With 20+ years experience, our global regulatory experts combine your product goals with our deep experience (pre-clinical, clinical, CMC, safety, and quality) and scientific depth on similar approvals to create a solid regulatory strategy.

  • Bullet Up-to-date on global regulations, both at a clinical study level and on a country-by-country basis with the help of our proprietary regulatory database for bio-pharma
  • Bullet Expertise in the development of rare diseases, biosimilars, cardiovascular, diabetes, infectious disease, immunology, oncology and NASH products
  • Bullet Coverage of small molecules, biological drugs and gene/cell therapy products


To learn how MakroCare can help you in developing

The First Step

Let's talk about how MakroCare can help you