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 increasing number of chronic diseases are among the few key factors that are leading to the growth of Pharmaceutical industry. These factors, combined, call for an improved medication, which in turn leading to drug innovation.
Innovating a drug involves many critical phases. Right from identifying a lead compound in the process of drug discovery to ensuring that the end product is safe and effective for the end user, 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: The pre-clinical research is mainly conducted on microorganisms and animals for answering basic questions about its safety
- Clinical Research: Involves drug testing on people, which is further divided into Phase I, II, III, IV of clinical trials
- Health Authority (HA) Review: HA review teams thoroughly examines the data submitted by manufacturers for drug registration and decides whether to approve or reject the end product
- 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 HAs.
- 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 or physician assistant or qualified nurse, an OTC can be ordered and consumed 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, and efficacy while marketing. To do so, HAs worldwide overlook and ensure the best practices put forward.
With many of their drugs are in various stages of lifecycle (development, yet-to-be-marketed and global expansion), Pharma companies may face challenges in aligning with market standards for necessary drug registrations, approvals and compliant market-entry. They are:
- Tracking down various region-specific HA regulations pertaining to:
- Quality and Assurance
- GxP Practices
- Audit and Validation
- Lifecycle Management
- Dossier Compilation
- Regulatory Procedural Complexities
- Publishing and Submission
- Dossier Preparation
- Labeling, Artwork Design and Pack Management
- Medical Writing
- Aligning With and Meeting 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 assists manufacturers navigate the global Pharma Regulatory regime to standardize procedures, centralize systems, and streamline Regulatory submissions for drug classifications, drug 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 end-to-end drug approvals. With a widely distributed consultant network, Freyr offers a path to approval across multiple jurisdictions.