Biologics Services

Biologics Regulatory Services

Biological products encompass a diverse array of items, including vaccines, blood and its components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can consist of sugars, proteins, nucleic acids, or intricate combinations thereof. Alternatively, they may exist as living entities, such as cells and tissues. These biologics are derived from various natural sources, including humans, animals, or microorganisms. Advanced biotechnological methods and cutting-edge technologies are used for the manufacturing of biologics.

Biologics differ from conventional drugs in that the latter tend to be chemically synthesized and their structure is known. Whereas most biologics and complex in structures that are not easily characterized.

Challenges in obtaining regulatory approval for biologic products.

Obtaining regulatory approvals for biological medicinal products is a multifaceted process that involves rigorous scrutiny by global health authorities to ensure safety, efficacy, and quality. This tends to be because of the complexity of the biologic product. Some of the challenges pertaining to the regulatory approval process for biologic products include conducting comprehensive preclinical studies to assess safety and efficacy of biologic products in laboratory settings; submitting results of pre-clinical studies to authorities as part of the Investigational New Drug (IND) application; preparing and submitting comprehensive New Drug Application (NDA) or Biologics License Application (BLA) submission to regulatory agencies; responding to queries and requests for additional information from regulatory agencies during the review process in a timely manner; obtaining approval for product labeling to ensure it accurately reflects the biologic products characteristics and instructions for use; developing and implementing risk management plans to identify, minimize, and communicate potential risks associated with the product.

Successful navigation through these processes & steps is critical for obtaining regulatory approvals in order to support biologic market penetration and patient access.