Lavida Services

Services are highly needed with current regulations upgrades and tightened pharmaceutical controls by Regulatory bodies across the globe.

Will impact the pharmaceutical industry in Europe and Middle East regions by providing below services:

Quality Management System

Regulatory Services

Product Development Services

Commercialization & Marketing Support

Qualification & Validation Services.

Providing Access Solutions

QMS And Compliance Services Will Help Clients Adhere To The Highest Global Quality Standards In A Cost Effective Manner, These Services Include But Not Limited To Upgrading Pharmaceuticals Facilities Good Manufacturing Practices (CGMP) To The European EMA, US FDA And Gulf Central Committee (GCC)  Standards, Which Will Help Clients To Expand Access To Key Markets And Provide High Quality Products To Patients In These Regions.

Planned Updates And Training Workshops To Help Clients As Well As Key Connections With Authorities To Facilitate Submissions Of Files And Follow Up.

LavidaPharma will provide these services to customers to qualify their facilities and equipment used for pharmaceuticals manufacturing, storage and distribution in accordance with regulatory requirement for GMP renewals.

Lavida pharma will provide innovative marketing tools and help developing marketing plans link to key distributors in the region sales force effectiveness and launch readiness compliance trainings.

Lavida pharma will provide access solutions to key markets with various models focused on efficiency and cost effectiveness as well as offer solutions on fast track and better value propositions.

LavidaPharma will have its own state-of-the-art pharmaceutical Product Development Lab and small scale production area.

The current know how with Dr Ghazzal and proven track of providing high quality products formulas ,will enable us to offer  complete ready to use generic product files  ready to be submitted for registration in  MENA, Gulf Countries and Europe.

Product development work at LavidaPharma  will be done in accordance with  FDA/EU Current Good Manufacturing Practice (cGMP) regulations for product development.

LavidaPharma consultancy will be dedicated to create and upgrade customers work standards & Systems according global guidelines for these service units:

Pharmaceutical Manufacturers Services

LavidaPharma pharmaceutical consultancy will provide pharmaceutical manufacturers with the following consultancy services:

Quality System Upgrading (GXP) According to Current FDA/ EU Regulations Which Include:

    • Current Good Manufacturing Practices (cGMP).
    • Good Documentation Practices (GDP).
    • Good Laboratory Practices (GLP).
    • Good Storage & Distribution Practices (GSDP).
    • Good Cold Chain Management Practices (GCCMP).

Validation & Qualifications

    • Qualification protocols preparation & execution for utilities, instruments & equipment in drug manufacturing facilities & drug stores.
    • Validation protocols preparation & execution which include process validation, cleaning validation & analytical method validation.
    • Site master file & validation master plan preparation.
    • Calibration/preventive maintenance protocols & programs preparation.

Regulatory Affairs issues:

    • Registration files preparation for MENA and Europe region.
    • Common Technical Document (CTD & eCTD) files preparation for GCC, EU, &US markets.
    • Regulatory issues assistance & follow up with regulatory authorities & principals.

Pre-Inspections for Facilities, Which Include Preparation of GAP Assessment Reports & Generation of Task Plan, to Assist The Companies to Get GXP Approvals.

Complete System Establishment (With SOPs & Flowcharts Generation) Which Comply to Current FDA/EU Standards for The Following Departments:

    • Quality Assurance.
    • Production.
    • Quality Control.
    • Warehouses.
    • Engineering / Utilities.
    • Research & Development(R&D).
    • Compliance.
    • Shipping & Distribution.

Product Development (R&D) Services: Development of Products in CTD Format for Registration in MENA, EU, & US Market Which Include:

    • Pre-Formulation Studies.
    • Formulation Studies.
    • Stability System Programs.
    • Analytical Methods Development & Validation.
    • Trouble Shooting in Production Department.

Lab Design for Regular & Cytotoxic Product Development.

Total Staff Recruitment Solution, Sourcing & Screening Process.

Training in All Technical Issues.

Organogram Establishment for the company structure.

Job Description Preparation.

Drug Stores & Distributors Services

LavidaPharma will provide drug stores /wholesalers, logistics companies, distributors & shippers with the following consultancy services:

Gap  Assessment  &  Pre-Inspections  on  Facilities,  Utilities, Personnel,  &  Equipment  & Quality/ Work Systems to Provide a Task Plan for Corrective Actions Needed to Comply with GSDP Standards.

Quality System Establishment / Upgrading  According to Current FDA/ EU/ WHO/ HC Regulations, Which Includes:

    • Good Storage & Distribution Practices (GSDP).
    • Good Distribution Practices (GDP).
    • Good Practices for Handling of Cytotoxic Products.
    • Good Practices for Handling of Potent Products.

Time & Temperature Sensitive Products (TTSP) Handling System Establishment / Upgrading According to Current FDA/ EU/ WHO/  HC Regulations, Which Includes:

    • Good Cold Chain Management Practices.
    • Good Vaccine Management System.

Regulatory Affairs Issues:

    • Registration  files  preparation  &evaluation  according  to  current  CTD  format requirements.
    • Regulatory issues assistance & follow up with regulatory authorities & principals.

Storage Facilities Design Review & Amendments to Comply with Current Regulations:

    • Design review & amendment of storage facilities to include different products status classifications, especially those with limited access.
    • Security measures assessment.
    • Temperature / Humidity mapping, recommendation on shelving & loadingConfiguration.
    • Storage conditions zones determination.
    • Equipment Sourcing & Selection.
    • Cold Chain Tools Sourcing & Selection.

Qualification/ Mapping/ Verification for:

    • Cold Rooms & Fridges.
    • Transportation Vehicles.

Validation of Ice Boxes & Shipping Containers.

Sourcing &Selection of Proper Temperature / Humidity Monitoring &Recording Systems.

Work System Establishment & Documentation:

    • Revising of the current applied system.
    • Establishing needed work SOPs in compliance with current GSDP.
    • Defining the proper communication channels between different departments.
    • Defining responsibilities with clear tasks.

Staff Selection, Evaluation & Training.

LavidaPharma Formulation & product development

Product development is a core competence of the company, with over 30 years in the area of product development and products registration in EU/ US markets as well as in MENA and GCC region.

Trouble-shooting and process optimization of an already available formula at a customer site (already developed products and processes) is also a major task of the Product Development Lab. Such work is done to increase the yield, lowering the manufacturing time, and modifying the formula/process as needed in a way that will not necessitate re-registration of work or new clinical studies. These studies are done based on the Post

Approval Changes Protocol adopted by the FDA. The changed formula and process will be under the system of change control and will lead to robust process/ formula that will minimize the trouble shooting to the maximum.

Additionally, the processing of the products of high production volume can be optimized to minimize the manufacturing time, production cost, especially for expensive high selling products.

Product Development  Objectives

    • To develop the pharmaceutical products at the highest international standards in a cost effective, and best-quality manner; Design effective and efficient formulas and manufacturing processes to achieve and maintain product quality and performance.
    • To assist pharmaceutical manufacturers in the development of high quality products with optimum cost and speed to market. It will allow these companies to focus on increasing production capacity and introduction of new lines.
    • To allow the introduction of high quality products to the market at the right time; these generic products will be available in the hands of the consumers at comparable quality to the brand and at affordable cost.
    • Save the money and time wasted by the manufacturers resulting from frequent trouble- shooting cases and low process efficiency related to poor development.
    • Ensure  practical  and  real  mechanistic  understanding  of  how  formulation  and  process factors impact product performance.
    • Establish specifications based on science and risk.
    • Facilitate more regulatory flexibility for post approval continuous improvement (improving productivity and reducing variability).
    • Minimize knowledge uncertainty that drives the need for specifications with unnecessarily tight acceptance criteria.
    • Provide process understanding to minimize the need for “re-validation” to qualify.
    • Make frequent changes necessary for continuous improvements.