Do it Right the First Time

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We help you streamline and implement the best possible CMC development program. With our expert advice, you can minimize your time to submission by ensuring from the start that studies and documents are completed and prepared properly.

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Submit with Confidence

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We prepare targeted, focused, and clearly understood regulatory documents that are expertly packaged for FDA review.

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Write Concise FDA Submissions

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Rely on our extensive regulatory and technical expertise to generate high quality and tightly organized regulatory submissions. Improve the likelihood of FDA approval with every submission.

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Implement Effective Development Strategies

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Take advantage of our experience and expertise to help meet your development goals through wise and efficient use of your precious human and capital resources.

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Strengthen Your Regulatory Team

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Whether you are in a large firm, a small start up group or a virtual company of independent partners, Regulatory Interlinx will provide full CMC support and carefully tailor our assistance to complement your development efforts and the abilities of your regulatory team.

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Eliminate the Confusion of Government Regulations

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Navigating the bewildering maze of FDA regulatory requirements can be daunting and overwhelming. We help you gain control and bring order and predictability to the process.

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Maintain the Highest Quality Standards

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Rely on us to develop and implement quality assurance systems to meet GMP requirements. We will also assist you in auditing and managing your vendors for compliance.

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Manage Contractors with Confidence

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We will help you identify reliable contractors and assist in their management during all phases of product development.

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Effectively Manage Development Costs

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With our expert and careful oversight, get the most for your money from contractors. We will help you design milestones and define time lines appropriate for your goals and objectives.