We engage with the sponsers and support them by focusing on the following criteria:
1.Quality
2.Timeliness
3.Consistency Of Performance.
4.Project cost
4.Regulatory inspection history of the the contract organisation.
5.and whether the facility for manufacturing is CGMP compliant.
Suntech Pharma Solutions can provide the services for answering your key milestone hurdles and support your organisation reach its goal,with respect to compliance and regulatory submissions with a leading expertise.
Suntech Pharma Solutions can help you provide the most experienced organisations for the on-going international and national activities with respect to:
QMS
Relevant GxP compliance with applicable GxP regulations and quality standards and inspection history (if known)
Competence to deliver the service
Capacity to meet service demand and any potential variations
Ability to supply a service at acceptable quality while meeting timelines
Secure business capable of long-term supply, invests in up-to date technology
Commitment to sponsor’s business, ie, not de-prioritizing due to new businesses
Infrastructure and quality culture
CRO’s/CMO’s physical assets and capability
Scalability of the facility/organization
Facility’s/organization’s delivery metrics