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WHY CHOOSE US ?

Covering all facets of GMP compliance, we address your precise needs.

Deeply ingrained knowledge of global regulations assures compliance on an international scale.

Customized services aligned with your unique requisites guarantee practical, effective outcomes.

Covering all facets of GMP compliance, we address your precise needs.

Our team of seasoned professionals, experienced in the pharmaceutical industry, offers practical GMP compliance solutions.

A broad understanding of international regulations aids in expanding your market reach while ensuring compliance across diverse regions.

Let Qualicare Technology be your partner in elevating Quality Management and Regulatory Compliance for pharmaceutical excellence. Contact us now to embark on a journey towards enhanced product quality and regulatory success.

GMP is more than just a QMS tool; it’s a business tool. We take pride in being a driving force behind your success, considering our clients as integral partners in our journey toward elevating the pharmaceutical industry.

The illustration list of scope of work is as under:

To provide comprehensive and complete guidance including road map finalization, resource identification for the non-sterile oral dosage facility across all functions (QA/QC/Engineering, Manufacturing and warehousing) to receive major regulatory approvals.
Evaluation of gaps as per the current GMP requirements.
To help the Company in preparation of Qualification/Validation documents of its all manufacturing equipment, facility and utilities including the Air Handling unit and utilities.
To provide qualitative guidance to the entire vendor’s of equipment/AHU/utilities in executing the qualification and validation including review of all internal as well as external protocols thereof.
To guide the Company in establishing system procedures (SOPs/protocols/policies/ Manual) for maintenance of QMS and timely site approval from regulatory bodies which shall also include the training that needs to be provided to the Company’s officials as may be required from time to time for ensuring timely regulatory approval.
To set up quality systems at site and to provide guidance on continued efforts to seek regulatory approvals of the site from EU, UKMHRA, USFDA, TGA Australia, TPD Canada, MCC South Africa, MOH Ukraine etc.
This includes review and guidance on the entire QMS as per cGMP requirement. Expected timeline would be 10-12 months from the filing/submission of the site transfer batch documents or any new product dossier in any EU country for Company’s manufacturing facility. The USFDA certification take a timelines of 18-24 months.
Customer connections for triggering the EUGMP inspection are also done by QualiCare Technologies in addition to company’s own efforts.
To provide guidance to QA/QC staff on continuous basis for setting up the entire Quality Management systems and ensure that the site succeeds in qualifying a clean regulatory and customer inspections.
To provide guidance and setting up systems and procedures for men and material movement, material management systems including containment policies for the site looking at the nature of manufacturing in adjacent blocks to the unit under the scope of approval.
To provide continuous guidance on documents up-gradation and Supervision on all aspects of GMP except technology.
To provide training on need identification to the Company employees and staff. The training spread would be from QC, QA, Engineering, warehousing to regulatory affairs.
To provide complete guidance on Process validation protocols, Method validation protocols, stability study protocols and designing of specification at all stages of the manufacturing process for filing of the EUGMP file.
To help in filing the response to deficiencies arising out of any inspection, whether customer or regulatory bodies.
To provide any regulatory guidance that the Company shall seek related to the GMP certifications for all the advanced markets.
To provide all assistance that may be necessary for successful execution of validation batches for site transfer. For EU site transfer batch, batch execution costs shall be borne by the Company in case it is a site transfer project of any new customer.

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Home >>Why Choose Us?

WHY CHOOSE US ?

The illustration list of scope of work is as under:

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