Overview

Pharmaceuticals as an industry is rapidly growing across the globe. Being one of the crucial sector of life sciences it deals with innovating and developing lifesaving drugs. Aging population, increased income, changing lifestyles, and newly evolving chronic diseases are some of the few factors that leads to ever-rising importance of Pharmaceutical industry. These factors combined call for an improved medication which in turn leads to drug innovation.

Innovating a drug involves many critical phases. Right from identifying a lead compound in the process of drug discovery to ensuring the new drug is safe and effective for the end users, the process includes:

  • Discovery and Development: Involves research and testing of molecular compounds and new technologies followed by developing a new drug in the laboratory
  • Pre-clinical phase: Pre-clinical research is mainly conducted on microorganisms and animals for answering basic questions about its safety
  • Clinical Research: Clinical research involves drug testing on people to ensure which further includes Phase I, II, III, and IV clinical trials
  • Health Authority (HA) Review: HA review teams thoroughly examine the data submitted by manufacturers and decides to approve or reject the drug

Classification of drugs

  • Innovator/brand-name drugs and generic drugs

While an innovator drug, one that has a trade name, is protected by a patent and can be produced and sold by the company holding the patent, a generic drug is an equivalent to an innovator in terms of dosage, strength, route of administration, quality, performance and intended use and costs almost 30-80% lesser. When the patent protection for an innovator drug expires, generic versions of the drug can be offered for sale in consent with concerned health authorities.

  • Prescription drugs and over-the-counter (OTC) drugs

While a prescription drug can be availed only when the pharmacist dispenses it on the order of a physician, physician assistant, or qualified nurse, an OTC can be ordered by the consumers themselves. 

Pharma Industry Regulatory challenges

A drug developed and marketed should promote safe and better health. Considering its tedious development process and different classifications, there might be deviations in establishing the patient safety without any trackers or validations. Hence there are plethora of laws and regulations to govern the testing, patenting, safety, efficacy and marketing. Health authorities worldwide overlook and ensure the best practices put forward.

With many of their drugs are in different stages of life cycle (development, yet-to-be-marketed and global expansion), Pharma companies could face challenges in aligning with market standards for necessary approvals and compliant market-entry. They are:

  • Tracking down various region-specific health authority regulations pertaining to:
    • Quality and Assurance
    • GxP Practices
    • Audit and Validation
    • Life Cycle Management
    • CMC
    • Dossier Compilation
  • Regulatory procedural complexities
    • Publishing and Submission
    • Dossier Preparation
    • Labeling, Artwork Design and Pack Management
    • Medical Writing
  • Aligning and complying with mandatory deadlines
  • Lack of Regulatory personnel in-house

 

Freyr for Regulatory needs of Pharma Industry

As a proven Regulatory partner for renowned pharmaceutical companies worldwide, Freyr is specialized to navigate the global Pharma Regulatory regime to standardize procedures, centralize systems, and streamline Regulatory submissions for registrations, licensing and obtaining market approvals in a quick TAT. Freyr, with a specialized focus on the entire Regulatory value-chain provides cost-effective regulatory solutions and services. We customize the process with respect to service and software assistance for the end-to-end device approvals. With a widely distributed consultant network, Freyr offers a path to approval across multiple jurisdictions.