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Innovation and Product Development Transforming Ideas to revenue
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Marketing and Sales Generating Value from the Market
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Mergers and Acquisitions Exploring new ways to growth
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LavidaPharma pharmaceutical consultancy will be dedicated to upgrade customers work standards & systems according to cGXP global guidelines for these service units:
Pharmaceutical Manufacturers Services
LavidaPharma pharmaceutical consultancy will provide pharmaceutical manufacturers with the following consultancy services:
1. Quality System Upgrading (GXP) According to Current FDA/ EU Regulations Which Include:
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- Current Good Manufacturing Practices (cGMP).
- Good Documentation Practices (GDP).
- Good Laboratory Practices (GLP).
- Good Storage & Distribution Practices (GSDP).
- Good Cold Chain Management Practices (GCCMP).
2. Validation/ Qualifications:
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- 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.
3. Regulatory Affairs issues:
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- 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.
4. Pre-Inspections for Facilities, Which Include Preparation of GAP Assessment Reports & Generation of Task Plan, to Assist The Companies to Get GXP Approvals.
5. Complete System Establishment (With SOPs & Flowcharts Generation) Which Comply to Current FDA/EU Standards for The Following Departments:
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- Quality Assurance.
- Production.
- Regulatory Affairs.
- Quality Control.
- Warehouses.
- Engineering / Utilities.
- Research & Development(R&D).
- Compliance.
- Shipping & Distribution.
6. Product Development (R&D) Services: Development of Products in CTD Format for Registration in MENA, EU, & US Market Which Include:
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- Pre-Formulation Studies.
- Formulation Studies.
- Stability System Programs.
- Analytical Methods Development & Validation.
- Trouble Shooting in Production Department.
7. Lab Design for Regular & Cytotoxic Product Development.
8. Total Staff Recruitment Solution, Sourcing & Screening Process.
9. Training in All Technical Issues.
10. Organogram Establishment for the company structure.
11. Job Description Preparation.
Drug Stores and Distributors Services
LavidaPharma will provide drug stores /wholesalers, logistics companies, distributors & shippers with the following consultancy services:
1. 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.
2. Quality System Establishment / Upgrading According to Current FDA/ EU/ WHO/ HC Regulations, Which Includes:
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- Good Storage & Distribution Practices (GSDP).
- Good Distribution Practices (GDP).
- Good Practices for Handling of Cytotoxic Products.
- Good Practices for Handling of Potent Products.
3. Time & Temperature Sensitive Products (TTSP) Handling System Establishment / Upgrading According to Current FDA/ EU/ WHO/ HC Regulations, Which Includes:
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- Good Cold Chain Management Practices.
- Good Vaccine Management System.
4. Regulatory Affairs Issues:
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- Registration files preparation &evaluation according to current CTD format requirements.
- Regulatory issues assistance & follow up with regulatory authorities & principals.
5. Storage Facilities Design Review & Amendments to Comply to Current Regulations:
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- 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 & loading configuration.
- Storage conditions zones determination.
- Equipment Sourcing & Selection.
- Cold Chain Tools Sourcing & Selection.
6. Qualification/ Mapping/ Verification for:
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- Cold Rooms & Fridges.
- Transportation Vehicles.
7. Validation of Ice Boxes & Shipping Containers.
8. Sourcing &Selection of Proper Temperature / Humidity Monitoring &Recording Systems.
9. Work System Establishment & Documentation:
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- 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.
10. Staff Selection, Evaluation & Training.
LavidaPharma Formulation and product development
Product development is the core competence of the company, Dr. Nadia has spent 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 Lab Objectives:
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- 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.