We provide a comprehensive GMP/GLP & ISO Quality services for the pharmaceutical industry. We stand apart from others in the way we handle the requirements, we indulge in the customers system from top to bottom and make them self-supporting through training in those aspects which are lacking predominantly.
Even we differentiate ourselves from others in respect to the filing activities keeping in mind of the customer’s confidentiality and to that view we maintain the secrecy to that extent.you can find a detailed overview of the services provided by Anilatmaj here.
Compliance
Anilatmaj carries out the detailed
review of facilities, systems and documentation and carries out the
gap analysis.
It then creates a detailed plan in collaboration with the client and systematically guides to upgrade the facilities to comply as per the international regulatory requirements.
Additionally, it creates a formal
compliance program for the client and also carries out regular
audits to check for compliance to the quality management system.It
can effectively integrate the ISO/CGMP requirements in the
QMS.
Training
We also impart training in CGMP,
GLP, regulatory compliances, ISO 9001:2008 etc., updating your
staff's technical competence and expand their areas of knowledge
and expertise in quality management, thereby increasing their value
to the company or organization.
Vendor Audits
We carry out Audits of suppliers and vendors of Drug Substances and drug products with a detailed audit report which can be shown to the regulatory auditors
Technical
Writing
We have experienced Technical
Document Writers available to write quality documents.
Our GMP Consultants work very closely with your technical personnel to ensure that the Quality System complies with USFDA and other international regulatory requirements like MHRA, EDQM, Australian TGA, KFDA, COFEPRIS (Mexican Authorities), MCC to name a few .
The quality documents will not only be compliant, but also quite elaborate, easy to understand and follow.
GMP SERVICES
Consultants - FDA GMP consultants, Health Canada GMP consultants or WHO GMP consultants.To provide the consultation services in the field of Quality to the expectation of the standards viz., ISO 9001,CGMP of US, Europe, Canada, Japan, Korea to name a few
Auditing Services - Professional Quality GMP Audits by experienced auditors. To assist in successful completion of regulatory or customer audits for a successful growth in the sector of business
Raw Material Sourcing - We can source your raw materials and qualify your suppliers.
On-Site GMP Training - Let us do the training at your site.
Online GMP Training - We can train through the internet.
Stability Studies - Let us help you determine your product expiry.
Quality Control Testing - We can perform testing on your materials in our qualified laboratory or help you in yours.
Regulatory Affairs - Let our regulatory experts help you out, or do the work for you.
Method Development - Having trouble with an analytical method? We likely have it ready to go. Ask us.
Method Validation and Transfer Services
Calibration and Validation Services
Protocol and Report Writing
Submissions - Let us make the regulatory submission process easy for you.
Standard Operating Procedures
Annual Product Review
Investigations
To provide the consultation services in the field of Regulatory for filing the Drug master files (DMF) to the expectation of US, Europe, Canada, Japan, Korea to name a few
To provide services for the documentation requirements as applicable for the pharmaceutical companies viz., SOPs, Manuals, Qualification, etc
We have what it takes to help you succeed in today's marketplace. Let us open the world to your organization.
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