Pharma Engineering Services

Horizon Pharma has always been the first choice for a large number of healthcare and pharmaceutical firms looking for first-rate, customized scientific services. We are the leaders, providing a multitude of scientific services about healthcare and the pharmaceutical industry. We, with our experienced and qualified staff around the globe, offer cutting-edge, tech-savvy services. Staying abreast with all the latest technology inventions that can facilitate the growth in the healthcare and pharmaceutical industry,

We provide cost-effective & time-bound total engineering solutions for projects – CONCEPTS TO COMMISSIONING.

We are duly equipped to shoulder the accepted responsibility to your complete satisfaction.

Scope of operation:

Turnkey projects including design, supply and installation
Engineering Consultancy (Conceptual, Basic, and Detailed)
Feasibility Study Report
Architecture design/ Civil structural design
Electrical Engineering design
Project Management and Execution
HVAC engineering design with BMS
MEP / Utility engineering design
Machinery selection
Environmental engineering
Fire safety design
Neutraceutical plants /Veterinary
Equipment Procurement Assistance
Modular Clean Room services with Epoxy Flooring
Pharmaceutical Process and Utility Equipment
Black Utilities with Mechanical Piping
Direct Impact Utilities
Documentation for Statutory compliance
GAP analysis for Pharmaceutical plants and safety audits

Validation /Qualification/Periodic Verification

Training on Protocol & Performance of Activity
Planning of Validation / Qualification Activity
Effective Execution of Validation / Qualification activity
Effective & Scientific Report Writing,
Trend Preparation and Summary Report etc.
Water System Qualification
HVAC System Qualification
Air Compressor Qualification
Area Qualification
Process Validation
Cleaning Validation
Method Validation
Temperature Mapping
Computerized Systems

Documentation

Preparation of Site Master File (SMF)
Preparation of Validation Master Plan (VMP)
SOP’s Writing related to R&D, WH, QA and production, and EHS
QMS & Data Integrity Policy Writing
Preparation of Validation/ Qualification Protocol & Reports
Development & Preparation of Training Material Preparation of HR / Admin Polices

Regulatory Affairs

Preparation and compilation of dossier Modules M2 & M3
Compilation of CTD data for R&D parts for regulatory submission
Variation project submission and closing the complex queries related to new raw and packaging materials (RPM)

R&D and product development Services

Designing of Pharmaceutical R&D Centre
Development of New pharmaceutical products – Tablets / Capsules / Powders / Eye Drops / Injections / Creams
Sourcing of RPM (Raw and packing materials)- USDM/CEP sources
Setup of specifications (Raw materials, Packaging materials, and stability specifications)
Analytical Method development for finished products
Material resourcing and planning software system (MRP system) for effective handling of RPM
Simplification of Complex Manufacturing Processes
Trouble Shootings observed during scale-up/manufacturing site transfers
Technology Transfer and Scaling-up of technologies from lab scale to Production floor
Interpretation of Pilot Bio Equivalence data and fine tweak the formula, if required to get a bio-equivalent Product

Quality assurance/Compliance