Regulatory Affairs

Regulatory Affairs

PRE-SUBMISSION

We assist our clients in all matters ranging from administrative all the way to complex scientific authoring for submission purposes. 

Some of the services offered in this area are:
  •  Strategic planning for MA submission 
  •  Authoring of Documentation for all Modules for CTD format
  •  Gap Analysis and Dossier Compliance
  •  Technical documentation preparation - ERA, RMP, overviews, summaries
  •  Pre-auditing and prepare for GMP Inspection
  •  Batch release and testing documentation
  •  Finalisation and review of full submission dossier
  •  Publishing eCTD and versioning


SUBMISSION/REGISTRATION

Apart from the regular services of submission in its simplest form, Pyxis is able to provide ongoing strategy and inputs during the process. Our team understands that Agencies are made up of individuals and opinions can vary. Depending on the source of the query we can assist understanding the root cause of such deficiencies and assist in responding, negotiating or even deferring responses to the agencies. Our team is also experienced in leveraging other successful MA grants in other parts of the globe to assist in Agencies to make decisions in their own assessments.

Some of the services offered in this area are:
  •  Fully compliant dossier submission in EU markets
  •  Support(technical, administrative and regulatory) for Deficiency response and coordination
  •  Facilitation of dialogue with Agencies during registration process
  •  Support of finalisation of procedure/national phase
  •  Management of referrals - regulatory and scientific
  •  Troubleshoot/risk assessment of major concerns - strategy adaptation
  •  Assistance in GMP Inspections, CAPA and communication with Inspectors


POST-AUTHORISATION

We are able to provide standalone or ongoing services for post-approval maintenance. This can range from long-term support of all variations, renewals, PV and eCTD versioning through to a standalone submission of a change request to an Agency. We are able to provide services in Life-cycle management that could minimise costs and meet critical timelines in order to ensure MAs are kept up-to-date.

Some of the services offered in this area are:
  •  Variations, renewals, PSUR and eCTD lifecycle maintenance
  •  Large volume variations, grouping for EU 
  •  Consolidation of renewals, preparation of dossier and submission
  •  Pharmacovigilance activities
  •  MA transfers and associated variations during acquisition transactions