Welcome to
TECHNOGxP ENTERPRISES
Welcome to
TECHNOGxP ENTERPRISES
Welcome to TechnoGxP Enterprises
TechnoGxP Enterprises is one of fast growing GXP Service providing company with its headquarters in Mumbai and subsidiaries company in EU & UK London. The firm committed to providing innovative, quality and affordable medicines for healthier life, we maintain the highest standards of quality; the products meet relevant pharmacopeia standards and statutory requirements. In addition, the company ensures that all the steps involved in design, development and manufacture of a product leads to the intended level of quality performance in the market.
TechnoGxP Enterprises is already registered or in process of registering in below country
Kenya
Peru
Tanzania
Uganda
Ghana
GMP pre-audits, Compliance advice and Bridging support, QMS documentation,Facility upgradation advise,Mock up Inspection,QP Audit,EU GMP Inspection to certification hand holding,Annual Report Submission.
Gap Analysis Audit
•Gap Assessment Audit
•Gap Assessment Report Submission.
•Management meeting - Next Stage
EU GMP Preparation
• Regular visits to verify facility, utility, laboratory, personnel and quality system • GMP Inspection application • System upgradation advice
EU GMP ACCREDITATION
• Securing EU GMP certification
• Updates on EudraGMP
• Annual report submission
• Renewals insepction support
WHY CHOOSE US
Our Services
GMP Excellence : EU/PICS/TGA/Health Canada
GMP pre-audits,compliace advise and bridging support, QMS documentation, facility upgradation advise,mock up inspection,QP audoit, EU GMP inspection to certification hand holding , annual report submission
Drug Product Regulatory - EU, UK, Australia, US, Canada, WHO & Emerging Markets
End to End Regulatory Services covering Regulatory Strategy, Scientific Dossier Writing, Submission to Health Authority, Exigencies response, Pricing approval, Marketing Authorization Approval & Product Life Cycle Management
Biosimilars & Vaccines Regulatory Support
BLA review, Scientific writing and CBER submission under 351(k) pathways with USFDA, Centralised application under Article 10(4) with EEA, Expert intelligence for biosimilar licensing in BRICS-TM markets.
EDQM Preparation & API CEP/DMF Services
DMF/ASMF/CEP scientific writing, Submission with Agency, support in resolving questions, Third Party API QP audit, QP audit Report, CAPA preparation, QP Declaration, CEP Certification, EDQM GMP support.
Third Party QP Audits, Vendor Qualifications & Due-Diligence
Third Party QP Audits, Vendor Qualifications & Due-Diligence Third Party QP Audits, Vendor Qualifications & Due-Diligence
Portfolio Partnerships
Portfolio Projects across the value chain, ranging from market specific portfolio strategy, defining regulatory pathway, product development, commercial launch & local partnership
