CPC reviews the existing Quality System and helps in up-gradation of the same. It assists in the review/ preparations of :
CPC helps in the preparation of following types of DMFs as per FDA guidelines.
Compilation of Open and Closed parts of DMF.
CPC has expertise to convert the
DMF into eCTD DMF.
Addressing DMF deficiencies or reply to the assessor’s queries
Be it a small / start up company or an established company, Inspection can turn disaster if not handled well.
CPC helps you in turning an Inspection into a great business opportunity and make a long lasting impression on the regulatory body. Its services include:
If there are any 483 observations or audit observations CPC closely work with the Company to address the same. It also helps Company to give reply to Warning Letter, review of the documentation and submission to FDA.
Since its inception CPC has assisted in 109 successful International Inspections.
Started in 2004.
The first a Green Field Project - Titan Laboratories, Mahad, Maharashtra for making modified release drug Delivery Systems. It has been approved by EU GMP, Korean FDA, TGA Australia etc. Following this CPC have under taken several Green Field and Up-gradation Projects - API’s & FORMULATIONS.
The project division 's services include:
CPC imparts various training programs on GMP to meet Quality and Regulatory requirements. Its personnel regularly attend training programs organized ECA in ICH Q7 GMP guidelines and Auditor Training course as well as advanced GMP Topics like
CPC PROVIDES FOUR EFFECTIVE PACKAGES FOR CONTROL OF DATA INTEGRITY RISKS
COMPUTER SYSTEM VALIDATION
TRAINING ON DATA INTEGRITY AND ETHICS
RETROSPECTIVE DATA VERIFICATION OF ELECTRONIC RECORDS AND PAPER
We have necessary expertise for carrying out 3rd party audits on your behalf to ensure that the auditee remain in state of compliance.
CPC has APIC certified auditors.
Benefits of Virtual Audits
CPC has strong relationship with a number of Indian companies and can act as an interface between the Foreign and Indian companies in identifying the right partner, products and technology.
CPC can also provide end to end marketing services to Indian companies looking to sell their products/APIs abroad.