Regulatory Affairs

At Choice Pharma, we have the experience to gain approval for your product responsibly and efficiently. Our expertise ranges from first-into-humans through the development plan and into the market. Our expert team, including former authority regulators and industry specialists, applies in-depth regulatory knowledge to manage the complex process smoothly and effortlessly, leading to an impressive track record of success.

Our regulatory support services include:

• Strategic regulatory consultancy
  We can advise you on how to meet the regulatory requirements your clinical development programme needs to satisfy. We can also liaise with the EMEA, FDA, PDMA and other regulatory agencies to ensure an efficient approval process from initial clinical trial approval to market authorisation.
• Clinical Trials Applications
  We can compile and manage Clinical Trial Applications under the Clinical Trial Directive, US IND and other regional requirements.
• Marketing Authorisation applications
  We can submit and manage Marketing Authorisation applications via the EU centralised or decentralised procedure and via the FDA, PDMA or other regulatory authorities. We can also translate all regulatory materials into national languages in compliance with regulations.

Medical Affairs & Consultancy

Throughout the drug development process, your objective is to achieve your product's goals. Our consultancy service helps you define what those goals are and develop a consistent, strategic plan to achieve them.

Our consultancy services include:

• Target product profile development
  Your product profile dictates the licence you will receive, which ultimately dictates your market. We can help you define your target product profile and then design a clinical development programme that is tailored to produce data to support the profile.
• Brand essence development
  The importance of branding to the success of a product cannot be overemphasised. Even during early clinical development, branding has a role to play. We can help you develop your brand vision by defining a brand essence and developing the brand architecture to support it.
• Market landscape definition
  We can perform thorough market analysis to help you decide how you need to shape the market to achieve maximum success for your product.