Services

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Notarisation Apostilled and Legalisation of Regulatory Documents (Certificate of Pharmaceutical Products (CPP), EU product authorisations, Good Manufacturing Certificates, Manufacturing Authorisation and declarations,  Price Certificates). We support in preparing regulatory dossier as per regional requirements. We have significant experience and understanding of authoring regulatory dossiers addressing right level of CMC registered details.

We also process Patent & Trade Mark Documentation, Powers of Attorney, Assignments, Authorisations and Companies House Certificates.

We provide support for Due Diligence/Gap Analysis Regulatory Strategy Dossier Preparation - Marketing Authorisation, eCTD Authoring Review of Dossiers for ongoing regulatory issues. Post Approval Maintenance Variations/Renewals Manufacturing site transfer 

CTA Application Support

IMPD Authoring 

 Large team of pharmacologists and experienced toxicologists have been the key to quickly create approx 900 PDE/ADE and OEL reports for APIs and different routes of administration. These reports are periodically updated to ensure incorporation of latest data.
Sponsors can select the reports they require from the following list and contact us for quick delivery. 

Health-Based Exposure limit assessment (PDE/ADE and OEL)

 We has 6 expert toxicologists (DABT/ERT) who calculate, permitted daily exposure (PDE)/ acceptable daily exposure (ADE) values that is unlikely to cause adverse effect, if an individual is exposed at or below this dose every day for a lifetime. OEL is derived from PDE to find out the exposure limit to which, a person working in the manufacturing area may be exposed everyday (for 8 hours shift) for a lifetime without getting any adverse effect. According to OEL, OEB is decided and safety gears may be set up at the manufacturing site.
As per EMA, PICS and APIC guidelines calculating PDE has become mandatory from 1st April 2018 for all those companies who are exporting to European markets.
https://www.ema.europa.eu/en/setting-health-based-exposure-limits-use-risk-identification-manufacture-different-medicinal
Reference document:
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PDF/169.13 KB)
https://apic.cefic.org/publications.html
Reference document:
Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, September 2016 

We manage your safety and pharmacovigilance needs at any stage of product/device development to ensure quality and compliance: 

· Clinical trial safety: Phase I-IV, from data entry to case closure, full processing, including expedited/periodic reporting 

· Post-marketing safety: AE case processing, reporting, signal detection, literature search and review, product complaints

· Safety regulatory submissions: Dedicated subject matter experts in safety regulatory legislation and submissions 

· Safety database: Dedicated support team with expertise in working both in customer and in-house safety database 

We have highly qualified drug safety scientists with experience in industry-specific pharmacovigilance services and a deep knowledge of regulatory legislation and dedication to providing quality safety services.