ESPL Regulatory Consulting

Clinical / MAA / NDA Submissions

Our multidisciplinary team provides flexible and comprehensive support with preparing Clinical Trial, MAA and NDA submissions for small molecule and biological submissions.

 

Our multidisciplinary team provides flexible and comprehensive support for Clinical Trial, MAA and NDA submissions for both small molecule and biological products.


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Within the EEA, we have prepared and submitted Clinical Trial Applications (CTAs) in numerous countries for both small molecule and biological products (including writing Investigator Brochures (IBs), Investigational Medicinal Product Dossiers (IMPDs), and other CTA documentation).  Our local RA teams have also supported Ethics Submissions in some EEA countries, and we have CT expertise in-house to support our clients with monitoring and /or auditing.

ESPL has an established track record of managed/coordinated national, Decentralised, Mutual Recognition and Centralised EU procedures, including the national elements of multi-state procedures. 

We also act as proxy MA Holder for submissions, where required. 

To assure continuity of EEA activities post-Brexit, ESPL has established a company in Ireland from where submissions are being made.


In North America, the team can plan, draft and supported IND, NDA and ANDA submissions, as well as NDS / SNDS submissions in Canada.

ESPL has a network of trusted local regulatory staff to support submissions and local agency interactions in other global markets, including GCC (Middle East), ASEAM (South East Asia) and Australasia.


For our drug substance manufacturer clients, we can plan, draft, submit and support activities for:

  • Certificate of Suitability (CEP) applications to EDQM
  • Active Substance Master File (ASMF) / Drug Master File (DMF) filings in the EEA, North America, Australia, GCC and ASEAN countries.

For Marketing Authorisation Applications (MAAs) and New Drug Applications (NDAs), we provide full service support for preparation your e-CTD Quality, Safety and Efficacy, Modules 1, 2, 3, 4 and 5, including:

  • Planning the submission and seeking procedural slots
  • Drafting the modules, formatting and data integrity checks
  • Publishing and portal submission

For more information on how ESPL can support your business, contact us via the form below, and we can arrange a consultation.

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