For Us, It Is Not "We Can’t Do That”, But Rather “How Can We Get It Done"?

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Regulatory Affairs (RA)

We help to ensure compliance with regulatory requirements relating to the development, registration and lifecycle management of medicines in Africa.

RA Services On New Medicine Registration

Companies that fail to comply with applicable regulations may face significant legal and financial consequences, as well as damage to their reputation and business operations. We help with:

  • Due Diligence
    We help with performing gap analysis on new dossiers to identify deficiencies.
  • New Registrations Applications
    We help with the compilation of dossiers for submission to relevant regulatory authorities.
  • Deficiency Responses
    We help with the review and compilation of responses for deficiencies identified by regulators.
  • Artwork
    We help with the review of the final artwork for new marketing authorisation.
RA Services On Variations

Regulatory affairs play a critical role in helping companies navigate the regulatory landscape and ensure compliance with regulatory requirements throughout products lifecycles. We help with:

  • Gap analysis
    We help to identify and classify variations and address common deficiencies.
  • Variation applications
    We help with the compilation of variations for submission to Regulatory Authorities.
  • Deficiency responses
    We help with the compilation of variations for submission to Regulatory Authorities.
  • CTD or eCTD baseline
    We help with the conversion of dossiers from old formats to CTD or eCTD.
  • Unforeseen (z-codes) variation applications
    We help with the process and requirements for applications for EMA z-codes variations.
  • Priority review applications
    We help with the process and requirements relating to priority review applications variations
RA Services on Renewals

Companies have a legal obligation to renew marketing authorisations after expiry to ensure that the quality, safety, and efficacy of medicinal products are maintained. We help with:

  • Gap analysis
    We help to identify and address common deficiencies relating to renewal of market authorisations.
  • Dossier compilation
    We help with the compilation of renewals of market authorisations for submission to Regulatory Authorities.
  • Response to deficiency queries
    We help with the review and compilation of responses for deficiencies during the assessment of renewals of market authorisation by regulatory authorities.
RA Services On Dossier compliance

Regulatory affairs play a critical role in ensuring that master documentation at the manufacturing sites are in line with the registered information in products' dossiers. We help with:

  • New medicine registrations
    We help to check newly obtained medicine registration dossiers against master documents, to ensure regulatory compliance prior to new products launch.
  • Market Authorisation Transfer Applications
    We help to check the dossiers received from the old holder against current approved masters to ensure regulatory compliance prior to product launch by the new holder.