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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?

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

  • 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.
  • Expertise in the development of rare diseases, biosimilars, cardiovascular, diabetes, infectious disease, immunology, oncology and NASH products
  • Coverage of small molecules, biological drugs and gene/cell therapy products

 

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