NAMSA healthcare regulatory consultants have considerable experience of compiling and reviewing specialized documentation and medicinal compound dossiers (the Typical Technical Doc [CTD format]) for drug/gadget merchandise. This encounter ranges from wound dressings to heart valves and drug coated stents.
Regulation firms searching for skills during the remediation of warning letters, consent decrees, 483’s or import bans
Contrary to a traditional staffing company, our recruiters are subject material industry experts who guarantee Just about every of our resources offers the understanding and knowledge you may need. We deliver much better expertise, faster and even more Expense-correctly than classic search firms.
Help Together with the pre-submission method whereby crucial issues pertaining to the ultimate submission will be talked about Together with the FDA
By streamlining seller administration, our FSP eliminates inefficiency, minimizes spending plan overruns, and gives higher-top quality services with the sector's top rated expertise. Savings scale Together with the size and period from the assistance offer and involve a complete Quality Assure to make sure responsible service.
In case you are presently an established business enterprise, you might have help with recovering from non-compliance difficulties resulting from an audit or help with building a whole new GMP facility. We can even supply back again-fill staff members to include intervals of absence or useful resource shortfalls on tasks.
PharmOut offers a wide variety of GLP, GDP and GMP education classes, all of that may be sent on-web-site or on the net, and inside a city in your area.
On the other hand, for providers that discover it challenging to outsource scientific trials or never want to cede control of the scientific demo process, there are other solutions to leverage outsourcing chances.
Our expert groups are wanting to help you thru each phase of product enhancement, making certain you increase value at Each and every phase.
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As your partners, we are able to negotiate the prospective minefield of regulatory compliance and regulatory due diligence with Perception, hindsight, and the crystal clear benefit of our one of a kind knowledge and working experience.
Our group of expert regulatory researchers can write the nonclinical, scientific, and CMC sections in CTD and traditional structure for your personal new drug and biologic apps.
We aid shoppers protected a wide variety of lifetime science assets for both contracted and immediate employ engagements with an ideal combination of skills, working experience, and motivation for succeeding in demanding and demanding initiatives.
We have an understanding of the complexities of jogging a existence more info science enterprise and have regions of expertise that come with every aspect of R&D, functions, regulatory affairs, high quality, and producing.