FDA Regulatory Affairs & Product Development Consulting
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30+ Years History With a Proven Track Record of Success
Regulatory experts, including former US FDA professionals
Our Expertise
Our leading experts are at the forefront of global regulatory updates, industry trends, and technological advancements offering our clients unparalleled strategic advantage and quality. Our commitment to excellence, our client-focused approach, and our dedication to advancing patient care make us your partner of choice as we work together to bring innovative medicines and technologies through the regulatory pathway.
Drugs & Biologics
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Medical Devices
The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.
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Combination Products
The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.
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Our Expertise
Our leading experts are at the forefront of global regulatory updates, industry trends, and technological advancements offering our clients unparalleled strategic advantage and quality. Our commitment to excellence, our client-focused approach, and our dedication to advancing patient care make us your partner of choice as we work together to bring innovative medicines and technologies through the regulatory pathway.
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Product development planning & regulatory strategy
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Full service nonclinical, clinical and CMC solutions
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Technical review and writing of briefing books, clinical study documents and full submission packages
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Measurement science, endpoint selection and biostatistics consultation
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Regulatory affairs management including US Agent services, management of FDA communications and commitments, and meeting support
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Regulatory operations/ePublishing
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Partial or full-time employee staff augmentation
Services by Product Type
Your Competitive Advantage
Cell & Gene Therapy
Technical, regulatory, and quality process support for cell and gene therapies.
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"I can’t say enough about how wonderful it has been to work with Biologics Consulting. The level of quality, speed, and professionalism has helped us accomplish the workload this year."