Knowledge is the key to gain a cutting-edge foothold, globally. At Prescription Pharma Support (PPS), we recognize the significance of continuous updated knowledge and believe it to be the fundamental impetus behind any pharma company with a global outlook.
PPS offers value through the vision and knowledge of professionals who have commendable experience in the industry.
“Knowledge is power!”
In today's world, knowledge talks. Knowledge that will grant you that edge, that advantage and give you power over the competition. Today, companies the world over are using this realization and transforming knowledge into an asset.
In the pharma and biotech industry, it is even more pronounced. With rapid advancements in technology, to stay ahead of competition, you have to keep abreast of the newest happenings around the world especially in the fields of pharma and biotech manufacturing, as well as research and development. What stays in constant focus is the continuous betterment of the quality of human life, through better drugs, better manufacturing technologies, better research and constant updation of knowledge.
Prescription Pharma Support Pvt. Ltd. today is a result of entrepreneurial vision, Self belief & hardwork of three entrepreneurs, Asha Shetty, Karen Carvalho & Nikhil Nagri.
We at Prescription Pharma Support Pvt. Ltd. (PPS) realize the importance of continuous knowledge as being crucial to the driving force behind any Pharma or biotech Company that needs a global advantage. PPS is your window to the latest trends and technologies that are constantly evolving and being adopted by the leaders in the pharma and biotech industries worldwide.
PPS offers value through the creativity and knowledge of professionals who have a wealth of experience in the industry. Our strength has been our strong networks with experts from all walks of the profession, be it the manufacturing and research industry, allied sectors, academia or the regulatory bodies.
“To become a One stop shop for Pharma training, talent, consultancy and sourcing.”
Our journey has just begun… so welcome aboard and let's get to know each other better.
In a short span of just 10 years,PPS has created a niche for itself as one of the leading professional services provider to the pharma industry globally.
Prescription Pharma Support Pvt. Ltd. would like to thank associations like Indian Pharmaceutical Association (IPA), Pharma Institute of GMPs, Parenteral Drug Association (PDA) India Chapter and All India Drug Control Officers Confederation AIDCOC, as well as International bodies such as American Association of Pharmaceutical Scientists AAPS, International Society of Pharmaceutical Engineers ISPE for giving us an opportunity to prove our mettle.
In the technology-sensitive Pharma industry, your “facilities” are at the “core” of your company’s health. Evolving your business Strategies would include bringing in innovative products, upgrading your quality systems in compliance with new regulated markets and preparation for even more stringent Regulatory authorities. PPS can help grow your business with comprehensive and confidential Technical Consultancy Solutions. Our Panel of Experts can revamp your existing facilities to adopt best practices to maximize your resources, setup new systems and facilities, or walk you through your newest Auditors with complete preparation and compliance. PPS Global Experts can help you adopt the latest in Special Technologies e.g. Pulmonary Drug Delivery Systems, and help you create a new niche segment in your product portfolio.
- Audit Preparation and Readiness for specific Regulatory Inspections - USFDA, EU, MHRA, etc.
- GAP Analysis in Manufacturing Processes : Implementing Lean Manufacturing
- Development and Manufacturing of Pulmonary Drug Delivery Systems
- Quality Systems Regime Setup
- Documentation and Dossier Review
- Plant Design and Setup
- Regulatory Strategy and R&D Lab Setup
And many more …
PROCESS WALKTHROUGH OF MANUFACTURING, FACILITY AND PROCESSES :
GAP ANALYSIS and PRODUCTIVITY IMPROVEMENT
PPS reviews your existing manufacturing facility and processes with the objective of Process Optimization tending towards “Lean Manufacturing Operations”. Project modifications will be proposed per the EU Directive and GMP and GDP Guidelines. PPS provides recommendations on aspects such as -
AUDITING SYSTEMS IN THE MANUFACTURE OF APIS
PPS reviews systems related to Quality and Manufacturing Systems, including Facilities, Equipment and Materials, Packaging and Labelling, and Laboratory Control Systems, in the Manufacturer of APIs.
Audit Preparation and Readiness for specific Regulatory Inspections - USFDA, EU, MHRA, etc.
PPS provides detailed assessment of your facilities in preparation for specific Agency Inspections through a Pre-Inspection Audit and Gap Analysis in cGMP Compliance of the Quality Systems and Processes. The Audit can be conducted for both Non-Sterile as well as Sterile Areas. Based on the Audit findings, PPS Auditors present a detailed Audit and gap Analysis Report with result-oriented action plans with regular review and implementation.
Quality Systems Regime Setup including Computerised Systems Validation
The existing QA and QC Systems and Processes at your Manufacturing Facilities can be reviewed by our Global Experts with the objective of achieving a level of compliance in accordance with specific regulatory agency guidelines. Similarly, the existing CSV SOPs, Systems and Processes can be reviewed with the objective of identifying the areas of improvement and troubleshooting.
REGULATORY FILING AND API DOSSIER REVIEW
PPS Expert Consultants can review your DMF's and relevant documents, keeping in mind Compliance to current regulatory expectations and filing requirements. Issues such as Genotoxicity, Impurity carryover, identification of starting material, metallic impurities, residual solvents etc. will be addressed aimed at minimising queries from regulatory authorities.
ADEQUACY GAP ANALYSIS for R&D : Filing Readiness and NEW PRODUCTS DEVELOPMENT
PPS provides assessment and review processes such as ANDA pipeline and dosage forms, Competence and capabilities, Equipment and facilities, Processes and monitoring tools, Procedures and practices, Documentation practices and controls, etc. In addition, PPS Experts can provide Gap Analysis templates for mapping ANDA filing readiness of your company and how to set and achieve targets in R&D and Product filing.
Also, Expert Consultants of PPS Panel can interact with your Formulations Development Team in order to identify and develop new products for specific markets, based on market intelligence and technologies available. Patent issues will also be reviewed and addressed.
Development and Manufacturing of Pulmonary Drug Delivery
Systems: Formulation Development for MDIs, DPIs, Nasal Sprays PPS Panel of Experts provide end-to-end solutions for Formulation Development and Manufacturing of Nasal and Pulmonary Drug Delivery Systems such as MDIs, DPIs and Nasal Sprays. PPS handholds you through the entire life cycle of Formulation identification, development and manufacture that spans Sourcing and selection of APIs, Excipients & Components - Valves, Canisters, Actuators, Stability studies, Process Development, scale-up and Validation batches, pilot plants setup and technology transfer upto commercial production.
Plant Design and Setup
PPS provides Consulting Services in Greenfield and brownfield Pharma projects. Our experienced Experts will provide solutions for every step of facility setup, right from design and layout of the facility, in accordance with specific regulatory guidance, right upto handholding through systems and process setup, inspections and approvals, upto commercial manufacturing and control.
Every progressive firm needs to keep an alert eye on where they stand in terms of market size, sector growth, opportunities and threats. These firms are either in the midst of expansion, by way of product line extensions, new product launches, or foraying into new markets and target audiences. Prescription Pharma Support conducts these GAP analyses for our associates.
A few of the market research projects that we have undertaken --
• Manufacturing Facilities Of MNC Pharma Plants In India
• The Indian Industry for Cosmetics
• Presentation Styles Of Oral Solid Dosage Forms
• Micronisation Practices In India
• The Market for Statins in India
• The Tablet Coatings Market in India
• Oral Solid Dosage Manufacturing in India
• The Market for Isolation Technology in India
• The Pharma Supply Chain and Logistics Market in India