WE KNOW SUBMISSIONS

YOU KNOW SCIENCE

See  how we help companies

just like yours.

 
 

WHO ARE WE?

JCRATL & ASSOCIATES, we ARE your Regulatory Operations & Lifecycle Publishing Support Team!

We work for you.  Bring your science and we will publish your submissions.

 

We are commited to changing the world one submission at the time.

 

Our team is dedicated in serving startups, sponsors, pharma, biotech and life science companies to provide regulatory operations support, submissions and dossiers publishing to global authorities.

 

Our service facilitates your product registration, pipeline, and regulatory lifecycle.  We provide you a matrix of processes and technical services to support your business' growth by ensuring global registration submissions compliance.

 

Tell us how we can colaborate and deliver a customized solutions consistent with your requirements. 

 

Regulatory Operations & Lifecycle Support Team

WHAT WE DO

At JCRATL & ASSOCIATES, we are dedicated to bringing the mastery of submission publishing to life sciences while raising the standard of success, and taking your products to new heights!

 

We offer flexible resourcing solutions and quality hands-on services to startups, sponsors and Life Sciences in need of submission project solutions.  Our outsourcing services offer flexibility to startup, small and mid-size companies.

 

Transition From Paper to eCTD?

JCRATL & ASSOCIATES offers full lifecycle management of the submission process with flexible options for submission publishing, compilation, and lifecycle maintenance.

 

We will guide you through the entire process of transitioning from paper to eCTD.  Our regulatory affairs professionals are experienced with the submission formats (eCTD, NeeS and paper) and support different submission types:  Investigational New Drug application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Drug Master Files (DMF), and many more.

  • We provide you resources to lend you hand in understanding the requirements.

  • We work with industry experts to enable you to make critical submission decisions with informed confidence.

  • We help you prepare electronic submissions with confidence to satisfy regional and global business objectives.