Quality target profiling for generics or biosimilars
Ensuring compliance and quality for your pharmaceutical products with QP release service
Helping you to develop generics and biosimilars
Quality target profiling is a crucial aspect of the development of generics or biosimilars. It involves establishing the desired quality attributes and specifications that the product should meet to ensure its safety, efficacy, and similarity to the reference product.
At Profarma, we specialize in quality target profiling for generics and biosimilars, utilizing a systematic and science-based approach. Our team of experts collaborates closely with clients to define the critical quality attributes (CQAs) that are essential for the product’s performance and therapeutic effect.
Within the European market, no medicinal batch can be made available for sale or distribution until it receives certification from a Qualified Person.
To streamline your product sales in Europe, Profarma’s QP ensures the commitment to quality and regulatory compliance before products can enter the market.
Frequently Asked Questions
Why is QTPP important in drug development?
QTPP is crucial for guiding the drug development process. It helps in defining clear objectives for product quality, ensuring that all development activities are aligned with regulatory requirements and patient needs. This ultimately enhances the efficiency of the development process and improves the likelihood of successful product approval.
How does Profarma assist in developing a QTPP?
Profarma provides expert guidance in developing a QTPP by leveraging our extensive experience in pharmaceutical development. We work closely with clients to identify critical quality attributes (CQAs) and align them with regulatory expectations and patient needs. Our systematic approach ensures a robust and comprehensive QTPP.
How does QTPP influence formulation development?
QTPP influences formulation development by defining the critical quality attributes that the formulation must achieve. It guides the selection of excipients, manufacturing processes, and testing methods to ensure the final product meets its intended quality profile.
How can I get started with Profarma’s QTPP development services?
To begin, contact Profarma through our website. Our team will discuss your specific needs and provide a tailored proposal for QTPP development to ensure your product meets all quality, efficacy, and regulatory standards.