|
Your inquiries begin with the Customer Support group within Technical Service; this group will continue to facilitate your interaction throughout other technical groups. Through consultation and personal interaction they assist global customers in a variety of ways.
| Technical inquiries related to cell culture applications and features: |
| |
|
Personalized baseline assistance and troubleshooting with application-specific issues, cell lines and more |
| |
|
Personalized product-specific assistance and troubleshooting with application-specific issues, cell lines and more |
| |
|
Cell culture technique consultation with non-scripted, personalized responses and solutions. Technical services associates are not measured on call volume, but rather on the comprehensiveness and thoroughness of their responses as they work with customers |
| |
|
Associates have real-world, hands-on cell culture experience and can help customers throughout the drug development pipeline, from those in emerging companies to those in commercially launched products |
| Product investigations and/or troubleshooting: |
| |
|
Investigative capabilities related to growth/productivity and performance, solubility, sterility, documentation, specifications, appearance |
| Generation of technical data: |
| |
 |
Stability and feasibility studies |
| |
|
Documentation review expertise regarding batch record, manufacturing record, storage, product handling, bench-top evaluation, troubleshooting |
| |
|
Long-term historical trending related to QC results, lot history, compliance |
| |
|
Assistance with identification of critical control parameters for raw materials and manufacturing processes |
| |
|
Thorough, timely responses to product and service deviations |
The Customer Support group also generates literature to support products, including specific use instructions, hydration, preparation protocols, application protocols and more and also generates technical bulletins, providing valuable tools for customers.
Regulatory-related issues have the dedication of an entire global group; we are the only cell culture-related company with dedicated customer-facing regulatory staff who can assist with compliance with all relevant regulatory bodies.
We continuously monitor international regulatory directives and trends to ensure compliance with relevant guidelines. We collaborate with you in understanding regulations to continuously improve our quality systems and validation processes. Through consultation and personal interaction the regulatory group assists global customers in a variety of ways.
| Documentation: |
| |
|
Component Sourcing Summaries (CSS) on a product – and customer-specific basis |
| |
|
Can be formatted to customers' submission requirements |
| |
|
The knowledgeable regulatory staff can react to Common Technical Documentation (CTD) requests |
| |
|
Capture of custom specifications and assistance of development and implementation of specifications to meet customers' requirements. Our approach to capturing your custom specifications related to testing, packaging and labeling with test data reported as you need it is unique and meets your individual requirements |
| Surveillance, interpretation and consultation: |
| |
|
Regulatory consultation and surveillance to continually monitor for changing regulations assures that you receive the most up-to-date and compliant regulatory information available |
| |
|
Import/export consultation and guidance on varied geographic regions, label compliance when shipping to other regions and defining definitions in terms of guidelines. These activities support your international import/export of critical raw materials and assist in supply chain management, assuring delivery without issues |
| Questionnaires and Chemistry Manufacturing and Controls: |
| |
|
We offer a single point of contact for the questionnaires across manufacturing sites. Rapid vendor qualification through questionnaires minimizes the need for on-site visits |
| |
|
Our level of expertise related to Chemistry Manufacturing and Controls (CMC), required for all New Drug Applications, Biological License Applications and renewals, is unmatched. You receive ready-made documentation to speed your regulatory packages within your submission process. All personnel receiving ongoing training on the needs of pharmaceutical customers related to CMC in their regulatory process |
|
|
Have a question or just curious?
|
|
