Shriji Pharma
Limited
Specialized In Pharmaceutical Quality Audits And Other Services
Invest your time and efforts on running your business. Leave the GxP auditing & Quality Compliance services on us.
- Trusted
- Experienced
- Professional
Services
What We do
We provide GxP auditing & consultancy services as per national and international regulations i.e. ICH (Q7, Q10 etc.), EU GMP, US FDA (21CFR 211 & 210) or any other market specific regulations.
01.
GMP Audit Services
We perform the high level of GMP audits of different types of suppliers as per different regulatory standards (i.e. EU GMP, ICH Q7, 21 CFR 210/211, ISO, etc. for GMP); the audits against the local country standards are also performed by our experienced auditors such as Brazil, Mexico, Canada, Australia/ NZ, China etc.
02.
Quality Compliance
- Pre and post-inspection audits (inspection preparation and remediation).
- Providing Quality/project support remotely as well as on-site.
- Training on any technical topics based on the client’s need.
- Provide the cost effective and highly qualified resources remotely to the international clients.
- Provide the guidance to obtain the EU/ US inspection preparedness.
- Gap assessment of the site and recommend the remediation plan.
- Guidance/ design of QMS for continuous improvement.
- Drafting the SOPs and other documents.
- Set-up of Computer Systems and CSV as well as ITQA compliance Or as required by clients.
03.
Regulatory Services
We have our Regulatory Affairs experts with the country specific experience in different activities such as:
- Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format).
- Documents review before the submission to eliminate queries/ rejection.
- Drug Master File (DMF) compilation for open and closed part.
- Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
- Expert reports on Quality, Pre-clinical and Clinical
- Orphan Drug Application Preparation and Submission.
- Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
- Assistance in Response to queries for submission to the Regulatory Agencies.
Why Choose Us
Accurate Record Keeping
Over 15 years of Pharmaceutical services experience for the clients around the world hence well versed with global quality requirements
Always On Time
To provide the high-quality Pharmaceutical services over the globe at cost-effective rates
Hard Working
To achieve the 100% customer satisfaction by having the prime focus on the customer’s need
24/7 Availability
To achieve the 100% customer satisfaction by having the prime focus on the customer’s need
