RegExcel Consulting

Helping you get regulatory approval


info@regexcelconsulting.com

Please contact us for a free no obligation discussion about your service needs.

 Regulatory Services

  • Technical advice for CMC, pre-clinical and clinical requirements for MAA and CTA;

  • Regulatory strategy;

  • Interpretation of EU Directives and EMA/ICH guidelines;

  • Classification and pathway advice (generics, biosimilars, borderline products, drug-device combos);

  • Assistance with regulatory agency interactions (meetings, scientific advice, submissions and responding to questions).

Post-Approval Services

  • Technical advice and strategy for post-approval variations;

  • Regulatory compliance and remediation;

  • Independent expert advice on failed/defective batches; 

  • Expert advice on 'unexpected' manufacturing/quality findings. Identification of key regulatory issues and solutions.

Other Services

  • Assistance in preparation of sensitive or complex communications (publications, patient/prescriber information);

  • Training (technical/regulatory affairs) for both Industry and regulatory agency staff;

  • Co-ordinating Industry feedback to new regulatory guidance documents;

  • Assistance with technical due diligence.