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Pharma & Biotech
Is your company looking for support within the development process of (complex) generics?
QbD Group can be your partner in the development and production of your pharmaceuticals.
QbD Group can be your partner in the development and production of your pharmaceuticals.
Industry challenges
In an era of rising costs, increased focus on global developments and manufacturing operations, pharmaceutical manufacturing demands detailed planning and a deep understanding of the regulatory, quality, and clinical aspects to bring these drugs to the market.
The regulatory life cycle of small molecule marketing authorizations can be resource intensive. Once the registration is obtained multiple variations are expected on annual basis. A sound understanding of the applicable scientific and regulatory EMA and ICH guidelines for the development of small molecule-based medicinal products is required to reduce the time-to-market.
Product development of new generic molecules starts early in the life cycle of the originator product (at the time of market launch), so long-term planning is essential. While small-molecule generics can be straightforward, complex generics require specialized expertise.
QbD Group can support pharmaceutical developers with full life cycle management for your marketing authorizations, such as ensuring that the CMC (Chemistry-Manufacturing-Control) section of the registration dossier (CTD Module 3) conforms with regulatory expectations.
Industry challenges
In an era of rising costs, increased focus on global developments and manufacturing operations, pharmaceutical manufacturing demands detailed planning and a deep understanding of the regulatory, quality, and clinical aspects to bring these drugs to the market.
The regulatory life cycle of small molecule marketing authorizations can be resource intensive. Once the registration is obtained multiple variations are expected on annual basis. A sound understanding of the applicable scientific and regulatory EMA and ICH guidelines for the development of small molecule-based medicinal products is required to reduce the time-to-market.
Product development of new generic molecules starts early in the life cycle of the originator product (at the time of market launch), so long-term planning is essential. While small-molecule generics can be straightforward, complex generics require specialized expertise.
QbD Group can support pharmaceutical developers with full life cycle management for your marketing authorizations, such as ensuring that the CMC (Chemistry-Manufacturing-Control) section of the registration dossier (CTD Module 3) conforms with regulatory expectations.
Why QbD Group?
EXPERTS IN LIFE SCIENCES
The QbD Group Regulatory Affairs team has the experience to guide manufacturers of small molecules and generics through the product development regulatory requirements and to generate a full registration dossier ready for submission to the competent authorities.
We can also support you in the actual registration process from the submission of a marketing authorization (MA) application until the MA is granted for generic and hybrid drug applications.
+10 years of experience
Full lifecycle support
Global presence
Best managed company
Resources
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Regulatory Affairs
Regulatory Affairs
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