Outsourcing Services

Submissions and other regulatory correspondences are moving more and more towards electronic formats, in fact some submission types are mandatory to be submitted in electronic formats and others are following quickly. If you are either moving from paper based submissions towards electronic formats or are just seeking help in managing your electronic submission lifecycle, our regulatory experts are glad to help you achieve your tasks and meet your deadlines.  To create and manage your submissions, we are using our Cunesoft Regulatory Platform, which allows us to share documents and submissions with you in a secure manner during the creation process, allowing you to review and participate in the process if needed.

Our regulatory team has profound experience in creating eCTD, ASMF, DMF, CTA, IND, MAA and other submission types. In particular we offer:

Submissions

Execution and monitoring of regulatory procedures:

  • National, decentralized, mutual recognition or centralized procedures (NP, DCP, MRP, CP)
  • New registration requests / approval renewals / variations
  • Support processing / notification of defects answer
  • CE marking for medical devices

Compliance

Conformity assessments:

  • Review and checking the quality of documents
  • Evaluation and assessment of quality approvals

Writing

Elaboration and editing of chemical, pharmaceutical and biological submission documentation:

  • Module 3 / Part II / CMC
  • Quality Overall Summaries
  • CEP Dossiers, DMF / ASMF
  • Site Master File / VMF

Regulatory has never been easier.

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