Services
Venus GMP Consultancy is having a team of Free Lance GMP consultants & specialized in, GMP Audits, Third party GMP audits, Audit Reports, Audit Compliance, Facility Up gradation, Validation, Support in GMP certification, GMP Training, Support in DMF/Dossier preparation. Support in handling FDA issues.
GMP Audits
We assist clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance of the real thing.
GMP Gap Analysis Audit
We will visit your site and perform an audit to determine where you need to improve and We are also able to offer assistance in correcting any deficiencies found
GMP Compliance
We monitor that Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
GMP Consulting
We can provide practical recommendations and advice on the implementation of Systems, Policies, SOP’s and Formats and help bring your current system into compliance.
DMF preparation
Regulatory submissions:
Compilation of dossier as per latest country specific guidelines.Drug master file (DMF) compilation for open and closed parts
GMP Training
Venus offers tailored onsite training to the Pharmaceutical, Biotech industries, and Food industries.Class room training is also provided to Officers/Executives/Managerial staff
Other Services Offered
Product Know-how List of countries for dossier We offers supportive services to Regulatory Departments of Pharmaceutical Companies Services / Our expertise : Compilation of Dossiers for various markets like ASEAN, AFRICAN, CIS countries, Regulatory (in CTD format). Free consultation: Pre-product …
01. Free consultation:
Pre-product registration / pre-dossier preparation inquiries
Dossier in CTD format
02.Assistance for Product Development:
Support for Process validation, Analytical validation & Stability Studies and related reports.
03.Assignments, handled by selected experts
Product development assistance, facility and system qualification and validation, training of staff in GLP and GMP
04.Technical Document Writing
We can help you write procedures and work instructions that your staff will actually use and can follow.