We have grip with the formats and content required for application of dossiers in various countries including US, EU. We can carry out partial or complete dossier writing on your company’s behalf. We will produce high-quality, compliant documentation and deliver it to the deadline we have agreed. Our electronic dossiers are also fully compliant with the current CTD format as specified in the relevant guidelines.
>Validation, with set of documents and evidences to ensure the consistent quality.
>Validation Summary Report
>Risk Assessment
>Deviations and Change Management
>Design Specification
>User Requirement Specification
>Installation Qualification
>Operational Qualification
>Performance Qualification
Pharmalutions has successfully executed Total 11 Projects
starting from Layout Designing
to execution.
Different assignments of Audits, Gap Analysis, Process Development and Validation, Analytical Method development and Validation and QMS Support for pre and post Audit are conducted on behalf of Indian and Multinational Company.
Pharmalutions has successfully executed Total 11 Projects
starting from Layout Designing
to execution.
Different assignments of Audits, Gap Analysis, Process Development and Validation, Analytical Method development and Validation and QMS Support for pre and post Audit are conducted on behalf of Indian and Multinational Company.
Admin. Office: A404, Business Square, Vishwalaxmi Co-Op Society, M.A. Road,
Near Railway Station,Andheri (West), Mumbai-400058, India.
Correspondence Address: C-9 Viral Apartments, 50 S.V. Road,
Opp. Shoppers Stop,
Andheri (West), Mumbai-400058, India.
GSTIN: 27AAFPS1831C1ZZ
Mobile: +91-9821149210 / +91-9920949210
E-Mail: pharmalutions9@gmail.com
contact@pharmalutions.co.in
Website: www.pharmalutions.co.in