Analytical Support During Registration
Guiding the regulatory landscape together
Expediting the pharmaceutical product registration process
Analytical support during the registration of a pharmaceutical product refers to comprehensive analytical testing and data generation to demonstrate the safety, quality, and efficacy of the product to regulatory authorities. This support is crucial for ensuring that the pharmaceutical product meets the required standards and complies with regulatory guidelines.
Profarma offers comprehensive analytical support during pharmaceutical product registration, including method (re)development and validation, quality control testing, stability studies, impurity profiling, and comparative dissolution studies.
Our team compiles detailed analytical data ensuring robust scientific evidence for regulatory approval.
Support during registration
Our services include:
- Analytical Method Development and Validation
- Quality Control Testing
- Comparative Dissolution Studies
- Purity, related substances
- Stability Studies
- Analytical Data Compilation
Frequently Asked Questions
What documentation is required for regulatory submission?
Required documentation typically includes:
- Method validation reports
- Stability testing data and reports
- Impurities profiles and certificates of analysis
- Batch manufacturing records
- Analytical test results and certificates of compliance
- Detailed reports on all conducted tests and analyses
How can I get started with Profarma’s analytical support services?
To begin, contact Profarma through our website. Our team will discuss your specific needs and provide a tailored proposal for analytical support during registration to ensure your product meets all regulatory standards.