Full complex support within Quality Assurance Compliance from QP services, EU Batch Release to complex certification of EU GMP by EU Authorities.

The enhancement and continuous improvement of Quality is the responsibility of every individual. As part of intent focus to our customers’ compliance needs, we conduct surveillance of new regulations, and monitor and implement new regulatory trends.

We acknowledge that it is essential to offer you a full range of service within our supervision. Our own Batch Release Site is set to provide you with access to whole EU territory.

Our services include:

Gap analysis and remediation

Preparation of eCTD modules 2 and 3

DMF preparation

QP services

Import documentation and licensing

GLP/GMP audit

Pre-approval inspections – finished drug product or API

EU GMP

Batch release (EU BRS) and analytical testing for batches

Warehousing

Our highly experienced specialist offers full technical and commercial assessment over European markets identifying opportunities of business grow, utilizing the latest IMS data.

We will provide you a complex strategy plan for market entry, with the right form (private label), arranging tailored made/build dossiers.

We have developed the environment that could produce market analysis; evaluate the molecule potential, advise on preparation of due diligence & ventures activities from business development to product development and from out licensing to in licensing.

Our highly experienced specialist offers full RA support:

Dossier Preparation &Review

Drug Firm Establishment Registration with US-FDA[United States’Food and Drug

Administration] (FEI [Facility Establishment Identifier])

EU full regulatory support in all 27 countries (National, DCP, MRP, Centralized

procedures)

Preparation of DMF [Drug Master Files]/ ASMF [Active Substance Master File] / CEP

[Certificate of Suitability] or (CoS) / KDMF/ Technical Packages

Regulatory Filing Support

Review

Response Strategy

Response Drafting

Response Documentation Review Issue Resolution Plan

Special issue work-up

Integrated safety summaries

Company core data sheet generation and maintenances

Safety and Surveillance Programs for investigational and marketed products

Risk mitigation and management plans

Risk evaluation and mitigation programs (REMS)

Quality control systems for off-shored PV services

Mock safety audits

Audit Periodic Safety Reports

Audit preparation

Data review, coding and narrative review, plus document verification on Adverse Event case reports

Placement of trained PV specialists at client companies

Eudravigilance support

XEVMPD

Performance and maintenance of MAH's pharmacovigilance Systems and risk management, and oversee

pharmacovigilance audits to assess regulatory compliance.

Timely submission, and quality of aggregated data reports (e.g. PSURs, Post authorization study reports, risk management findings) and other documents required by European Health Authorities.

Adequate quality assurance, control, performance, and measurement to include SOPs and work instructions to

cover all processes relevant to Pharmacovigilance.

All personnel involved in the pharmacovigilance system receive adequate training on all aspects of an EU regulatory mandate affecting pharmacovigilance.

PV RPP – local Responsible Person for Pharmacovigilance or Local Safety Officer

Literature searching

Aggregated reports (RMP, PSURs, ACO or preparing national versions of RMM)