Allied Regulatory Consulting has been serving drug, medical device and dietary supplement companies of all sizes for over 20 years. Our team is comprised of experts in dealing with the FDA and whether you are a start-up looking for basic advice or a large-size pharmaceutical looking for an established partner, we offer the experience you need at rates you can afford.
Our services include:
To learn more about the services we offer click here.
So why are we called "Allied"? Our name comes from the fact that we also offer additional support beyond regulatory affairs including clinical science expertise, biostatistics, electronic publishing, project management, medical affairs, manufacturing and design, marketing, quality, software development and even legal services.
Allied Regulatory Affairs Consulting - Providing professional regulatory affairs consulting services at affordable rates for almost 20 years.
Our services include:
- Regulatory Affairs Strategy - We can walk you through all phases, from early development to approval, to ensure your drug or device reaches market as quickly and efficiently as possible.
- Submission Planning and Creation - From scratch to complete, our team will walk you through what is needed to gain FDA approval. We can even write part or all of your submission - fast. Our team has authored hundreds of NDA, PMA, 510(k), IND and IDE submissions.
- Rx-to-OTC Switch - Our experienced team can assess your product for Rx-to-OTC switch viability and/or develop a complete strategic plan, including necessary studies, budget planning and guiding you through FDA interactions.
- Advertising and Promotional Material Review - We provide fast and thorough review of advertising and promotional materials for compliance with FDA or FTC requirements.
- FDA Meeting Preparation - FDA meetings are critical in the product development life cycle. We can make sure yours are executed to perfection.
- Training - Our team can provide a basic regulatory affairs course or fully train your staff to help build a strong long-term, internal regulatory affairs solution.
To learn more about the services we offer click here.
So why are we called "Allied"? Our name comes from the fact that we also offer additional support beyond regulatory affairs including clinical science expertise, biostatistics, electronic publishing, project management, medical affairs, manufacturing and design, marketing, quality, software development and even legal services.
Allied Regulatory Affairs Consulting - Providing professional regulatory affairs consulting services at affordable rates for almost 20 years.
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