Biologics Registration Services (RoW)

Biologics Registration Services (RoW)

Regulatory requirements for biological products vary based on the type of product and are vast. This includes recombinant therapeutic proteins, monoclonal antibodies, vaccines, and cellular & gene therapy products. Additionally, subsequent entry biologics or biosimilar products have separate Regulatory frameworks. Thus, a biologics registration services provider can help in understanding the Regulatory framework and requirements for each subcategory of biological products in the RoW countries.

Assessing the Regulatory requirements of RoW markets is more challenging due to the diverged Regulatory approach followed by different Health Authorities. Each type of biological/biosimilar product has different Regulatory requirements, and RoW Health Authorities have ever-evolving submission requirements. A proven Regulatory affairs partner can help overcome these hurdles and achieve successful submissions in RoW markets.

Templarpharma is a niche Regulatory service provider with significant experience in handling novel biologics, biosimilars, vaccines, blood & plasma products, and cellular & gene therapy products across RoW countries. Our team at Templarpharma can provide complete guidance on Regulatory strategy and biologics registration services.

Templarpharma and Biologics Registration

Our team can help navigate the complex and challenging Regulatory landscape in RoW countries by leveraging their expertise and knowledge. We understand that the Regulatory requirements for biological products are intricate and require a thorough understanding of the product and country-specific Regulatory information.

At Templarpharma, we offer a range of Regulatory services that can help you achieve successful submissions in RoW markets. Our services include Regulatory strategy development, product classification, gap analysis, dossier development, and submission support. We can also assist with post-approval Regulatory activities such as license maintenance and renewal.

Templarpharma Expertise

Our experienced team can help identify potential Regulatory hurdles including Biologics Registration and develop strategies to overcome them.

  • Templarpharma has a good pool of industry and ex-agency experts with more than 25 years’ experience in the biologics/biosimilars Regulatory space.
  • Templarpharma teams have excellent technical and scientific competencies to handle Regulatory issues associated with different Recombinant Expression Systems. Like (E.coli, Yeast, rCHO cells etc.) and different types of mammalian cell lines (Vero cells, MRC-5 cells, SPF CEF, etc.).
  • Templarpharma has a successful track record in handling Combination Products that are a combination of a biological product and a device (PFS, Pen injector, etc.).
  • Templarpharma can help with Regulatory strategy for global expansion of biological products/biosimilars. This includes strategic planning for clinical trials in specific regions, stepwise approach for product registration in multiple countries, strategic approach in Regulatory submissions, and HA query responses.
  • Templarpharma can help with drug development strategy for biosimilars. Including the identification of the reference medicinal product, demonstration of analytical similarity, clinical data waivers. Reducing the need for clinical data generation on local population, etc.
  • Templarpharma can provide Regulatory strategy/Regulatory insight reports for entry into new RoW countries. Additionally, Templarpharma can help set up agency meetings and represent sponsors to resolve scientific matters during product registration.
  • Templarpharma can also help with biological product registration in all RoW markets (Asia, Africa, LATAM, GCC, & CIS) and country-specific Regulatory gap assessment for the registration of intended biological product/biosimilar product.
  • Templarpharma can help with core dossier redaction/dossier preparation in country-specific formats. Necessary support for translation of dossier into the local language and Regulatory submissions management. Additionally,
  • Templarpharma can provide submission support for biological products CMC variations/amendments/supplements. To different Health Authorities and biological product lifecycle management and renewals.