Regulatory Governance

We provide Practical advice and help;

  • We can provide advice on product formulation, indications and dosage instructions. We'll resolve issues around products with specific difficulties and Provide you with an assessment of compliance with the EU GMP Guidelines Vol 4 and the ISO 9001, and 13485 standards.

Document preparation;

  • Work begins as soon as a new drug is discovered and continues long after product reaches pharmacy shelves. Stringent testing requirements have to be met and include accurate and detailed information along with convincing analysis and results.
  • Before documentation is submitted, it's down to regulatory affairs to ensure the right tests have been done at the right times - and with the correct interpretation of results.
  • Even when a licence to sell a new treatment has been granted, work doesn't end there. It's important to ensure a medicine's packaging is accurate and informs patient about benefits and potential drawbacks.
  • We'll manage implementation of responsible labelling and packaging to ensure new treatments are effective, have minimal risks and quickly reach your market. Good labelling can safeguard against drug misuse and prevent dangerous side effects. Accurate labelling can be as much a lifesaver as the drug itself.

Helping you with your electronic submissions

Many Regulatory Authorities will now only accept electronic-only submissions with eCTD. This applies to both new and existing submission types. Paper and other (non-eCTD) electronic formats will only be received as an exception PharmaConsult will assist you in preparing your own eCTD dossier by providing;

  • Regulatory support during pharmaceutical development, preparing CTD-ready documentation(CMC, Clinical, Non-clinical, labelling)
  • Development, preparation, assembly and submission of complete CTDs/MAAs for Europe and USA registration
  • Preparation of responses to regulatory authorities, comment letters, and assessment reports

Regulatory due diligence

Regulatory due diligence can be undertaken for potential licensing opportunities. Not only can we identify gaps in old dossiers, but we can arrange for and manage the additional studies to complete the dossier. And we’ll prepare the following documents on behalf of our clients:

  • Briefing documents for pre-NDA or EMA scientific meetings
  • Expert reports: CTD pharmaceutical, preclinical or clinical overviews.
  • Mutual Recognition response documents