Analytical Methods Development and Validation
Supporting early-stage method developments, transfer, and validation activities
Dedicated team for transfers, developments and validations
Profarma’s Analytical Methods Development and Validation services are designed to align with the demands of diverse regulatory bodies such as EMA, MHRA, FDA, ANVISA, and beyond.
Profarma’s GMP-certified and EMA-inspected EU site is dedicated to analytical method development and validation for CMC purposes of small molecules and biologics. We employ comprehensive and fit-for-purpose analytical procedures for transferring, validating, or developing methods from scratch.
Our experienced development and validation team has extensive expertise with a wide range of APIs, excipients, intermediates, and finished pharmaceutical products.
Analytical equipment
Chromatography and Spectroscopy
- HPLC/UPLC systems
- Gas Chromatography System
- UV/Vis spectrophotometer
- Fluorimeter
- AKTA Pure chromatography system
Stability Equipment
- Laminar flow unit
- Laboratory drying oven
- Thermal incubator
- Stability chambers
General Laboratory Equipment
- Centrifuge
- Milli-Q water system
- pH/conductivity meter
- KF-Coulometers
- Dissolution Test Apparatus
- Leak Tester
- Gliding Force Tester
- Disintegration tester
Biological and Sterility Testing
- TFF system
- Fermenter
- Capillary electrophoresis system
- Endotoxin Testing Endosafe System
- Sterility testing isolator
Frequently Asked Questions
What are different types of method transfer?
Profarma offers various types of method transfer to suit your needs:
Comparative Testing: Both labs perform the method independently, and we compare results to ensure consistency.
Co-Validation: Our team works with your lab during the validation process to align on performance criteria.
Revalidation: We revalidate methods to confirm they meet required standards.
Partial Validation: We validate specific critical parameters affected by the transfer.
These approaches ensure robust and reliable analytical methods tailored to your specific requirements. We take each project and offer our tailor made solution to meet your needs and regulations.
Can Profarma assist with troubleshooting and optimizing existing methods?
Yes, Profarma offers expertise in troubleshooting and optimizing existing analytical methods. Our team can help identify issues, recommend improvements, and implement changes to enhance method performance and reliability.
How does Profarma ensure the quality of methods transfer and development?
Profarma employs a systematic approach that includes rigorous validation procedures, thorough documentation, and continuous communication with clients. Our experienced team follows industry best practices and regulatory guidelines to ensure the highest quality and reliability.
How long does the methods transfer process usually take?
The duration of the methods transfer process can vary depending on the complexity of the method and the readiness of the receiving laboratory. On average, it can take anywhere from a few weeks to several months.
How can I get started with Profarma's methods transfer and development services?
To get started, you can contact us via our website. Our team will discuss your specific needs, provide a tailored proposal, and guide you through the process to ensure successful methods transfer and/or development.