GxP Services

Plant Mock Inspection

Mock inspections are very important for those companies that lack experience and expertise in authority’s inspection. Through mock authority inspection, enterprises can discover the deficiencies or insufficient inspection preparation in advance, which allows chances for improvement or adjustment. Mock audit services are being offered by our independently successful CGMP quality auditors. This mock inspection service will help pharma finished product manufacturing companies and/or API manufacturing facility who wants a quick review of their facility prior to the Agency visit. All this is to help enterprises to successful pass the authority inspection at one time.

NeoCubes can support according to USFDA GMP, EU GMP or PICS GMP criteria.

GMP Trigger

Each authority has their own procedure for inviting them for plant inspection. NeoCubes can support you to trigger the authority’s GMP inspection from EU authority, USFDA or PIC’s country. This service is applicable to finished product or API manufacturing unit.

Third Party Vendor Audit

NeoCube can provide you third party audit services for your requirement of auditing below listed facilities

  • API plant,

  • Finished product manufacture,

  • KSM vendor,

  • Excipient supplier,

  • Packaging vendors.

The main objectives for a third party audit are to assess the quality management of the whole organization, through its procedures and data processes. NeoCubes have a well experience team for such audit to provide your company a means to verify that third party vendors meet the applicable EU or FDA laws and regulations. We can conduct an audit within India, Asian countries, USA, Europe and UK.

We have a special service of managing your different vendors across all functions on annual auditing contract basis. This will be a cost effective approach.

GCP Services

NeoCubes can help you with effective clinical monitoring which is essential part to a successful trial and expediting a drug’s launch onto the market.

We can support you for;

  • Site selection and facility audit

  • Hospital site selection

  • Site initiation visit

  • Clinical study monitoring

  • Site closeout visit

Computer System Validation

NeoCubes can help you with computer system validation according to 21 CFR Part of USFDA 11 and Annex 11 or EU criteria with quality and cost-effective approach.

An essential part of any GxP computerized system validation strategy is to understand the impact that the system has from a regulatory perspective.

Our Validation Experts have many years of hands-on experience performing assessment of various computerized systems against the requirements of 21 CFR Part 11 and Annex 11.

PDE/OEL Reports

Health based exposure limits have to be determined for all APIs of human and veterinary medicinal products produced in multi-purpose facilities. We can help you to provide complete report of below.

  • Permitted Daily Exposure (PDE)

  • Occupational Exposure Limit (OEL)

These reports will be prepared by qualified team of toxicologists and non-clinical/clinical experts involved in the drafting of the reports.