Intelligence On New Medicine Registration
It's important for businesses and organizations to stay up-to-date on regulatory changes that could affect their operations, compliance requirements, and risk management strategies. We help with:
- Legislation, regulation and guidelines
- Regulatory plan development and implementation
- New formulation development strategies
- Stability data requirements
- Efficacy data requirements
- Registration pathways
- Clinical data requirements
- Posology and indications not in line with the SA innovator.
- Chemistry, manufacturing and controls (CMC) requirements
Intelligence On Variations
Regulatory affairs play a critical role in helping companies navigate the regulatory landscape and ensure compliance with regulatory requirements. We help with:
- Legislation, regulation and guidelines
- Re-formulation strategies
- Manufacturing process strategies
- Manufacturing process validation strategies
- Analytical methods development and validation strategies
- EMA conditions to be fulfilled not met
- EMA documentation to be supplied not met
- EMA unforeseen variations (z-codes)
- Data to support Type II variations
- API particle size and regulatory concerns
- API polymorphism and regulatory concerns
- APIMF procedure concerns
- Priority variations applications
- Stability data requirements
- Efficacy data requirements
Intelligence On Renewals
Companies must maintain the quality, safety and efficacy of medicinal products throughout their lifecycles. We help with:
- Legislation, regulation and guidelines
- Stability data requirements
- Chemistry, manufacturing and controls (CMC) requirements
- Efficacy data requirements