Submissions
8000 +
LCM Support
7000 +
MA Received
0 +
AM/LM
0 +

MEDATEQ LABS offer services like, Regulatory compliance (For Ex: Health authorities approved product information Vs what was actually implementing at the manufacturing plant level), manufacturing plant Auditing, corrective and preventive action (CAPA) management, computerized system validation, manufacturing equipment validation, IT system implementation, laboratory instrument validation, mock up audits to help in identify continuous improvement opportunities within their quality systems.

We drive business consultancy on various related to product selection, fixing the price, Appointment importer, Information on rules and regulations, market conditions, competition, product viability. we also offer our best services and supports for your business expansion to the following countries.
USA, Australia, UK
Asian Countries
European Countries
African Countries
CIS Countries
GCC Countries

PPC expertise in regulatory medical writing can assist companies with the following services.
Medical writing for Module 5 – Clinical Documentation
Medical Writing for Module 4 – Non Clinical Documentation
Module 2.4 to Module 2.7 – Overview & summaries
PSURs Reports – Periodic Safety Update Report now called PBRER – Periodic Benefit- Risk Evaluation Report
Pharmacovigilance System Setup
Risk Management Plans
Summary of Product ( SPC), Pack Insert
REPORTS
Quality
Pre-clinical
Clinical

Our Expert:
CMC strategy: strategy and planning from product development to new product filings, relevant health authority meeting support and interaction, due diligence, site rationalization, and submission coordination.
CMC authoring: Modules 2.3 and 3, NDA/MAA and IND/CTA, line extensions, dossier formulation/translation, and much more.
Lifecycle submissions: License renewals, annual reports, support of government and hospital tenders, CPPs, legal entity changes, and ancillary document collection/compilation.
Dossier review and compliance: Data review, dossier consistency, compliance audit, gap analysis and remediation, pre-approval preparation and pre-audit, due diligence assessment, and GMP inspection.

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