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FDA Submissions

 Embark on your clinical journey with confidence through our specialised services tailored for the FDA. From crafting robust Investigational New Drug (IND) applications to navigating the intricacies of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA), we offer a spectrum of services to streamline your path through the FDA.

Our expertise extends to Biologics License Applications (BLA) and strategic FDA meeting preparations, ensuring a proactive and efficient approach.

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Trusted by top-tier teams worldwide

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Investigational New Drug (IND) Applications:

  • Preparation and submission of IND packages including nonclinical and clinical data
  • Crafting pre-IND meeting briefing packages

New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA):

  • Support for NDA and ANDA submissions including CMC, nonclinical and clinical modules
  • Assistance with Complete Response Letters (CRL) and response packages

Biologics License Applications (BLA):

  • Strategic guidance for BLA preparation
  • Support with comparability studies and accelerated approval pathways

FDA Meeting Preparation:

  • Coordination of pre-submission meetings
  • Creation of briefing documents and meeting packages

FAQs

We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.

Here are some of the questions we get asked most often.

What experience do you have with ATMP clinical development?

Our team has extensive experience in Advanced Therapy Medicinal Product (ATMP) clinical development and is well-versed in how to deliver compliance throughout the development process. Get in touch with us for further information. 

Can you offer support in developing a clinical strategy at an early stage?
Which countries can you help cover in terms of licence management?
Do Apotech provide Qualified Person (QP) and Responsible Person (RP) services?

Featured case studies

Borderline device classification

Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…

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