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Boston Biodevelopment

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Expert Regulatory Leadership for Pioneering Drug Approvals

Founded in 2009 by Helena Correia, the company is a boutique regulatory affairs consulting firm specializing in delivering expert regulatory leadership and management at pivotal stages of drug development. The firm consists of highly experienced professionals, including former regulatory affairs leaders, who integrate seamlessly into clients' teams to provide sophisticated regulatory strategies and hands-on guidance for the development and approval of new therapies. Leveraging a deep expertise in a wide array of therapeutic areas and rare diseases, the firm excels in navigating the complex regulatory landscape for biologics, small molecules, cell and gene therapies, and gene editing products.

The company's consultants are recognized for their ability to drive regulatory strategy, ensuring effective planning, preparation, and defense of marketing applications and INDs, alongside strategic engagements with health authorities worldwide. Their services extend from pre-IND stages through product approval and life cycle management, offering a credible voice within development teams and management meetings. By providing comprehensive regulatory insights, the firm aids in mitigating risks and supporting successful pharmaceutical licensing deals, ultimately advancing client projects efficiently in a competitive market.

Expert Regulatory Leadership for Pioneering Drug Approvals

Founded in 2009 by Helena Correia, the company is a boutique regulatory affairs consulting firm specializing in delivering expert regulatory leadership and management at pivotal stages of drug development. The firm consists of highly experienced professionals, including former regulatory affairs leaders, who integrate seamlessly into clients' teams to provide sophisticated regulatory strategies and hands-on guidance for the development and approval of new therapies. Leveraging a deep expertise in a wide array of therapeutic areas and rare diseases, the firm excels in navigating the complex regulatory landscape for biologics, small molecules, cell and gene therapies, and gene editing products.

The company's consultants are recognized for their ability to drive regulatory strategy, ensuring effective planning, preparation, and defense of marketing applications and INDs, alongside strategic engagements with health authorities worldwide. Their services extend from pre-IND stages through product approval and life cycle management, offering a credible voice within development teams and management meetings. By providing comprehensive regulatory insights, the firm aids in mitigating risks and supporting successful pharmaceutical licensing deals, ultimately advancing client projects efficiently in a competitive market.

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