ISO Certification, ISO Consultancy, Lead auditor training, ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, AS 9100, NAAC, NRBPT, NABET, QCI

Pharma Consultancy

 

The following services can be offered to Pharma and Cosmetic industry

Pharmaceutical Industry (API & Formulations)

 

• Document & Data preparation assistance

• Dossier/submission preparation or review and filing for various drug regulators worldwide.

• Submission preparation to other worldwide agencies in European Countries, South America, Australia, and Asia

• Consideration of international regulatory requirements

• Meeting international filings

•  Revision of plans as guidelines change

Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process:

  Help you respond to regulatory agency questions

     GMP Auditing

•     Preparation of your organization for USFDA /TGA/MHRA/MCC/ANVISA /EDQM etc . GMP audits by gap analysis, document preparation, site specific verification & guidance.

•     ICH Q7a Gap Assessment

•     Quality Risk management adequacy verification as per ICH Q9

•     Help you establish quality systems in line with ICH Q10

II Cosmetic & Excipient Industry

• EFFCI (European Federation for Cosmetic Ingredients)

• ISO 22716:2007 Cosmetic cGMP compliance assistance

• EXCIPACT implementation assistance

• Gap audits and verification services to assist you in better system implementation

• Pharma, cosmetic, and excipient industry supply chain management solutions

Talk to us to know more details.