Looking for Pharma Consultancy, Cosmetic Consultancy, API & Formulations,USFDA, TGA, MHRA, MCC, ANVISA, EDQM, ICH Q9, ICH Q10, Cosmetic & Excipient, EFFCI, cGMP, Excipact, Supply chain management solution

The following services can be offered to Pharma and Cosmetic industry

Pharmaceutical Industry (API & Formulations)

1.  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

1.  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

Contact Dr. Shaktidhar Nayak on 9845313910 or drop an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it or This e-mail address is being protected from spambots. You need JavaScript enabled to view it