API sourcing is often linked to the drug development timeline and marketing schedule; a delay in the drug delivery can result in missing a milestone and could lead to negative financial consequences. With increasing stringent regulatory requirements coupled with increasing complexity of the molecules that are coming through the pipeline, it has become challenging to any pharmaceutical clients to source the drugs with in stipulated timelines.

Stark Associates offers customized and flexible sourcing and outsourcing of active pharmaceutical ingredients and intermediates. We have a strong network of life science industry players along with a team of professionals having in-depth knowledge in different stages of supply chain and regulatory requirements. Our highly trained team ensures uninterrupted, consistent and quick delivery of APIs and Intermediates in a cost effective manner with high quality standards.

Our services include:

• Facilitates transfer of new chemical entities, small molecules, fermentation and biologics.
• On site quality testing of APIs and intermediates depending on the destination of the delivery.
• Assist with relevant agency filings, inquiries and approvals about API master files.
• Support technology transfers.
• Negotiate contracts for client companies.
• Provide after sales complete support to the client companies.
• Be a facilitating partner between client companies and supplier companies.
• Provide regulatory and strategic advice on global sourcing for client companies.