Pharmaceutical

What does the pharmaceutical industry include?

The pharmaceutical industry includes products borne out of drug discovery programmes, extensions to existing product lines, longstanding brand lines and generics, and prescription-only-medicines. A major challenge for the pharmaceutical industry is the long and risky development process for new drugs; this is costly and can take over ten years from the laboratory to clinical trials. Typically, only around five out of 5,000 compounds that have been assessed at the pre-clinical stage will reach human clinical trials. Of these five, only one will eventually be approved by the regulatory authorities. The investment of time and cost in such processes places a significant strain on drug developers. Woodley BioReg provide early strategic advice in clinical, nonclinical, CMC/ manufacturing, and regulatory pathways to ensure clear routes and risk mitigation.
The assurance of product quality, safety, and efficacy.
Product maintenance throughout its lifecycle

Legislation and regulatory bodies
surrounding pharmaceutical products

The driving principle behind all regulatory requirements is the assurance of product quality, safety, and efficacy.

Pharmaceutical regulatory legislation includes controls that govern all parts of the product development and registration processes including:

• Patenting
• Product manufacture, validation, testing and release
• Technology transfer
• Marketing Authorisation application
• Product maintenance throughout its lifecycle

Pharmaceutical product manufacturers face a number of challenges, from developing analytical methods for high throughput screening of candidate compounds, to registering investigational new drug applications, filing Marketing Authorisation applications and ensuring cGMP compliance is maintained.

The governing bodies for the pharmaceutical industry include both national organisations such as the Food and Drug Administration (FDA) in the US, the Medicine and Healthcare Product Regulatory Agency (MHRA) in the UK, and regional bodies such as the European Medicines Agency (EMA). Interpreting the requirements of these boards of health, submitting relevant information, and responding to any queries and Requests for Information (RFI) is essential to securing and maintaining authorisation to produce and supply pharmaceutical products and cGMP.

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Recent trends in the pharmaceutical industry

Acquiring and developing generic products at the earliest possible stage

Typical trends in the pharmaceutical industry to maximise commercial benefits include:

  • Developing line extensions of existing products
  • Maximising the duration of Marketing Authorisation exclusivity
  • Acquiring and developing generic products at the earliest possible stage
  • Outsourcing manufacturing and licence maintenance activities
    to reduce costs and overheads

Many of these initiatives require planning and due diligence activities prior to implementation to ensure:

The regulatory standards are maintained reflected in the value of product lines.

Clear regulatory strategies are developed for compliance and conformance

Safe effective medicines are produced through the stringent management of suppliers and departments.

How Woodley BioReg can help the pharmaceutical industry

Woodley BioReg can assist the pharmaceutical industry at all stages of product development, providing trusted and professional advice on regulatory affairs and registrations, quality system, and project management through our flexible resourcing support.

Offering both remote support or consultants at your site — on a long term or short term basis — we provide a highly cost-effective means to access regulatory, clinical, nonclinical and quality resources on an as-needed basis that is and tailored to your requirement.