Regulatory Affairs Consultancy Services

Establishing Product Registration is a big undertaking and requires expert advice and careful planning. Our regulatory team will guide you through the legal and regulatory minefield and ensure a clear path to market.

We will;

  • Advise on importation of biological products including assistance with logistics, product release, and regulation.
  • Regulatory support for pharmaceutical development services including manufacturing, analytical chemistry, formulation development, microbiology, biotechnology and clinical research
  • Development, preparation and assembly of complete dossiers.
  • Preparation of responses to regulatory authorities, comment letters, and assessment reports
  • Representation to regulatory agencies and meeting planning
  • Regulatory submission critique including recommendations to help improve review of applications by regulatory authorities
  • Assistance in responding to compliance issues
  • Accurate labelling
  • Due diligence on product regulatory packages
  • Dossier submission to regulatory authorities

Practical advice and help

We can provide advice on product formulation, indications and dosage instructions. We'll resolve issues around products with specific difficulties. For novel forms of therapy, we'll represent your company. We'll meet with regulatory agencies to discuss key concerns and report back on best course of action.

Helping to resolve regulatory questions

Regulatory consultants act as a linchpin between many groups of people. From drug development teams through to marketing and legal affairs, as well as external health authorities.

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 Global 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