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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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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?

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Breakthrough Program

Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market. Apotech Consultants One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for…

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