Regulatory Affairs

your fast track to market

Janet Ellis
Regulatory Affairs Director

"I've handled the regulatory affairs of products from the biotechnology, pharmaceutical and complementary therapy industries including vaccines, novel dosage forms, generics, OTC products, herbal and homeopathic medicines, food supplements and borderline products.

I've project managed a wide range of submissions including EU mutual recognition, centralised and national marketing authorisation applications, clinical trial applications and submissions to Ethics Committees and has handled applications to regulatory authorities in Europe, The Middle and Far East, South America, Asia and Australasia."

Janet has a background as a pharmacist, with a PhD in pharmaceutical microbiology from the University of Nottingham.

• 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
• Preparation of responses to regulatory authorities, comment letters, and assessment reports
• Preparation and submission of European CTAs and ethics
  committee applications
• Due diligence on product regulatory packages for conversion
  of pre-CTD  dossiers into CTD format, or to ensure compliance
• Representation to regulatory agencies and meeting planning
  
  
  

  Regulatory constraints impact on all areas of drug development and supply, from the early stages of drug development through to final product manufacture, marketing and legal affairs. In addition, the constructive interaction with health authorities can play an important part in the drug approval process and the provision of appropriate information on medicines to doctors, pharmacists and patients.
  
  PDS consultants have the experience to take a broad view of the development process. This means we're well-equipped to tailor pivotal regulatory documents to optimise a company's chances of obtaining the desired product labelling, and to respond to questions raised by regulatory agencies. We'll review all questions and examine submitted data. We will work with agencies on your behalf to ensure an optimum path to market.
  
  Resolving your issues with a complex product
  
  We can provide strategic regulatory advice on product formulation, indications and dosage instructions. We can help resolve issues around products with specific difficulties. For novel forms of therapy, we can represent your company. We'll meet with regulatory agencies to discuss key concerns and report back on best course of action. We can also provide regulatory strategy advice on a range of other healthcare products, including medical devices, drug device combinations, cosmetics, herbal medicines and food supplements.
  We have compiled a number of applications to the advisory committee on borderline substances.
  
  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 conduct of the additional studies to complete the dossier.
  
  We'll prepare the following documents on behalf of
  our clients:
  
  • Briefing documents for pre-NDA or EMEA scientific meetings
  • Expert reports: CTD pharmaceutical, preclinical or
     clinical overviews.
  • Mutual Recognition response documents

Resolving your issues with a complex product

Regulatory due diligence

Document preparation