Over the last 15 years, Prescription Pharma Support Pvt. Ltd. is now globally recognised as a Pharmaceutical Solutions Provider, specialising in Technical Consulting, Recruitment and Training services to the Pharma and Biotech industry, with operations in several countries worldwide. PPS strength lies in our Talent Pool of Global Experts in specific fields - Manufacturing Operations, Quality and Regulatory Affairs, and Research & Development. PPS Experts have hands-on experience in their specific fields and will give you practical Solutions hand-holding you through your specific situations..
PPS provides Strategic Consulting Solutions to your specific Business Growth Objectives, be it - API Development, or Manufacture of Innovative New Products, Remediation Action Plans, or Inspection Readiness, or any stream that we can add value through the combined experience and expertise of our Panel of Global Experts.
PPS Specialises in Training Workshops, Corporate Cross-country Recruitments, Technical Consultancy, Strategic Sourcing, all focused on the Pharma and Biotech industry.
Prescription Pharma Support Pvt. Ltd. today is a result of entrepreneurial vision and constant endeavour to convert that vision into reality. Founded by 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 wealth of knowledge and hands-on expertise of professionals who have a vast plethora 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, as well as niche segments as well as mainstream Pharma and Bio-pharma.
“To become a One-stop shop for Pharma Training, Talent, Consultancy and Sourcing.”
In a short span of just 15 years, PPS has created a niche for itself as one of the leading professional services provider to the pharma industry globally with THREE main verticals :
Our journey has just begun… so welcome aboard and let's get to know each other better.
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 Auditors with complete preparation and compliance. PPS Global Experts can help you adopt the latest in Special Technologies e.g. Inhalation Drugs or specialised APIs, and help you create a new niche segment in your product portfolio, with new Sources for Finished Formulations or critical APIs.
FDA REMEDIATION ACTION PLAN, IMPLEMENTATION AND MONITORING
PPS hand-holds your team through the several activities when it comes to Remediation -
DEVELOPMENT AND MANUFACTURING OF SPECIALISED APIS AND FORMULATIONS SUCH AS INHALATION DRUG PRODUCTS
PPS Panel of Experts provide end-to-end solutions, right from Development upto Manufacturing of niche APIs (e.g. Statins, Gliptins, to name a few) as well as specialised Drug Products e.g. 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 - 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 brown-field 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.
AUDIT PREPARATION AND READINESS FOR SPECIFIC REGULATORY INSPECTIONS - USFDA, EU, MHRA, PIC/S, 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.
GAP ANALYSIS, CAPA-RCA and PRODUCTIVITY IMPROVEMENT
PPS reviews your existing manufacturing facility and processes with the objective of Process Optimization and Productivity Improvement. PPS provides recommendations and modifications as per EU Directives and GMP and GXP Guidelines. 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 SOPs, Systems and Processes can be reviewed with the objective of identifying the areas of improvement and troubleshooting.
AUDIT OF COMPUTERISED SYSTEMS VALIDATION, AND DATA INTEGRITY
PPS will conduct a complete Gap Anaysis Audit of your Systems and Processes, especially with respect to Computerised Systems Validation, Raw data transfer from systems to software, Laboratory Systems Software, Validation of Data and Audit Trails. Our Experts will also provide a complete Report, with recommendations, as well as hand-holding and periodic review, as needed.
REGULATORY FILING AND 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
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
Prescription Pharma Support Pvt. Ltd.,
PPS House, Plot No. 6. RSC 12 / 21, Sector No. 2,
Charkop, Kandivali West, Mumbai - 350 067.
MENA - MIDDLE EAST AND NORTH AFRICA
SOUTH EAST ASIA