Biological products

Vaccines, Insulin, Monoclonal Antibodies & Blood Products

These products are typically complex, high-value, and require stringent handling and regulatory oversight. In Pakistan, the market for biologics and vaccines is of high importance for public health; however, domestic production is limited. In fact, Pakistan imports all specialized vaccines and biologicals to meet its healthcare needs.

This indicates a strong opportunity for global biologic and vaccine manufacturers to supply the Pakistani market, but it also underscores the need for regulatory diligence to ensure safety and efficacy.

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Our Expertise in Biologics

Vireon Lab is equipped to assist companies dealing with biological products through the entire journey. Regulatory pathways for biologics can be more demanding – they often require detailed clinical data, cold chain compliance, and sometimes local clinical trials or bridging studies. We help prepare robust registration dossiers for vaccines and biologics, aligning with DRAP’s Biological Drugs rules and guidelines.

Our consultants can facilitate communication with expert committees or divisions within DRAP that specifically handle vaccines, biotechnology products, or biosimilars.

Building Trust in Biologics

We also focus on building medical community trust for new biologic therapies. Our team can organize scientific engagement – such as connecting you with local key opinion leaders (KOLs) in immunology or oncology who can champion the benefits of your biologic product. Educational workshops for doctors about proper use of biosimilars, for example, can be part of our marketing support in this sector.

In summary, for Biologicals & Vaccines, Vireon Lab provides a blend of regulatory acumen and strategic market access support.

Public Sector Engagement

For vaccines, public sector engagement is crucial since governments run immunization programs. We advise vaccine suppliers on how to register with government procurement programs, participate in tenders, and ensure that their product information and pricing align with the needs of public health initiatives.

We help our clients be ready to navigate the fast-track approval or emergency use authorization processes that might apply.

Frequently Asked Questions

What qualifies as a biological product under DRAP regulations?
Which authority regulates biologicals and vaccines in Pakistan?
What is required to register a biological product or vaccine in Pakistan?
How long does it take to get a biological or vaccine approved in Pakistan?
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