Consultation Services

Nitrosamine compliance—including NDSRIs—is critical for product approvability and for preventing costly market recalls. However, navigating this area can be highly challenging due to the scientific complexity and frequently evolving regulatory guidance.

At Pharviz, we've got you covered. Our team has deep expertise in managing nitrosamine-related compliance, with a proven track record of successfully supporting over 100 products.

We offer end-to-end solutions, including:

• Comprehensive risk assessments
• Confirmatory testing
• Formulation strategies to reduce nitrosamine levels
• Scientific justifications
• Preparation of regulatory reports and responses
   

Let us support you through every step of your nitrosamine compliance journey—with confidence and clarity.

Elemental impurities compliance is a critical regulatory requirement for product approval and long-term market sustainability. With strict limits defined under ICH Q3D and various regional guidelines, ensuring compliance can be complex and demanding—especially when dealing with multiple excipients, varied sources, and evolving expectations from regulators.

At Pharviz, we simplify this process for you. Our team has extensive experience in successfully managing elemental impurities compliance for a wide range of products and dosage forms.

We provide end-to-end solutions, including:

• Risk-based assessments in line with ICH Q3D
• Identification and evaluation of potential sources of elemental impurities
• Support for analytical testing and data interpretation
• Justifications and control strategies
• Preparation of regulatory reports and response packages
  

With Pharviz by your side, you can confidently navigate your elemental impurities compliance journey—efficiently and accurately.

Polymorphism plays a critical role in the development, stability, bioavailability, and patent landscape of pharmaceutical products. Selecting the appropriate solid form is essential—not only for optimal product performance, but also to ensure regulatory compliance and avoid potential patent infringement risks.

At Pharviz, we offer end-to-end polymorphism services to support pharmaceutical companies at every stage of development.

Our expertise includes:

• Solid form screening and selection
• Design and optimization of stable polymorphic forms
• Formulation strategies to enhance solid-state stability
• Patent non-infringement support and selection of non-infringing forms
• Ensuring bioequivalence with selected polymorphs
• Addressing polymorphic transitions during scale-up and storage
• Design, development, and validation of analytical methods (e.g., XRPD, DSC, TGA, FTIR)
• Testing and characterization of samples for polymorphic form and purity
• Preparation of regulatory justifications and responses to agency queries
   

With a science-driven and regulatory-aligned approach, Pharviz helps you de-risk your development process and ensure a smooth path to approval.