PHARMACEUTICALS
Pharmaceuticals
1. Technology Sourcing Services provided include • Literature search for a Drug Substance/ Drug Product • Intellectual Property Evaluation • Process Development and Validation • Analytical methods Development and Validation • Specifications -Raw materials, Intermediates, In-Process & Final product • Lab Demonstration, Plant Demonstration
2. Plant Set up Identification of the correct site meeting your current and future expansion needs is always a great challenge for any company, especially if it is your first manufacturing facility set up. Origo can support you in arriving at your final selection after a careful assessment of the short-listed sites by highly experienced experts by considering site grading, soil condition, availability of groundwater, suitability of the overall environment of the proposed site/s for the project (including moisture, neighbourhood factories, transport logistics, consistent electricity supply, mode of transport available) After understanding your purpose for the type of plant to be set up, we visit your site to offer the following services- •Proposed layout as per regulatory requirement •Technical support in machinery selection (Suppliers, vendors to contact) •Machinery installation for plant setup •Supervise construction leading to successful license approval We aim to provide the best solution leading to a successful conclusion. We have extensive knowledge of plant setup for various dosage forms including LVP, SVP, Tablets, capsules, liquid dosage forms, semi-solid dosage forms as well as bulk drugs and API. We also provide site master planning after site selection which includes- •Strategic Planning (Phase-out plan) •Number of buildings/ blocks envisaged •Site Analysis •Local regulatory compliance •Location & Orientation of the Buildings/ Blocks •Facility Amenities Planning •Building floor Levels •Landscaping
3. R & D Set up and Management We offer technical and financial advice to pharmaceutical research and development firms to create new processes for the R&D facility, improve the existing processes in the R&D facility, provide technical analysis and recommendations to management regarding the cost-effectiveness and development of new medicines, possible actions for deciding the best price of drugs in the market. R & D Management can lead to the successful completion of projects in a defined timeframe with a budgeted amount. However, due to the complexity of the research, this is not easy. More than 60% of projects in R&D department either go beyond agreed timelines or are completed with an increased budgeted amount. After the implementation of the R&D management model, productivity is increased with better timeline management and reduced budgetary expenses.
4. Formulation Development Origo provides support in the development of various generic dosage forms (Injectable, Ophthalmic, Tablets, Capsules, semi-solids and NDDS) for US and European markets (including filing ANDA and dossier preparation) as well as guidance in developing formulations for NDA and ANDA filing.
5. Analytical Development • Analytical method development (HPLC, GC) for raw materials, intermediates, drug substances (APIs), and drug products (Formulation) according to ICH guidelines • Qualification/validation of methods • Analyses of APIs/Formulation and related materials (raw materials, intermediates) • Troubleshooting and problem-solving of synthetic processes, comprised of method development/validation of HPLC and GC methods.
6. BA-BE Study Consulting • Outsourcing Bioavailability/Bioequivalence (BA/BE) study centres, conducting BA/BE studies in India for filing with different regulatory agencies (USFDA, EMA, DCGI, MHRA, ANVISA, TGA and others), • Conducting Phase III Clinical studies for NDA & NDDS products, Protocol development and data interpretation • Decision for study design, Application of statistical models & documentation • IVIVC Evaluation • Import license/No Objection Certificate (NOC) • Guidance support for BABE of highly variable (HVD) drugs and narrow therapeutic index (NTI) drugs • Pharmacokinetics consulting and recommending clinical experts
7. Scale-up & Technology Transfer Complete process validation as per regulatory and cGMP guidelines is provided for the establishment of validated high-quality commercial products using the concepts of Process validation, Critical parameters, Stability study and CMC documentation in CTD format. Technology transfer is a process that spans the key phases of pharmaceutical development right through to commercial manufacturing including: • Product transfers including API and drug product manufacture • Processing, packaging and cleaning operations • Pre-inspection approval assessments • Quality control – analytical method transfer We inspect the site to identify deficiencies in the facilities, provide documentation support, demonstrate 3 consecutive commercial batches for each product and continue support in technology up-gradation as well as troubleshooting for 1-year post-manufacturing start at commercial level. Our detailed services include support for- • Raw material specification, quantitative requirements, source of procurement and related safety data sheets • Product specification and Pharmacopeial reference • Process details including critical steps, time cycle and process flow chart • Specification of utilities, quantitative requirements and environmental conditions including classification for each processing stage • Standard Operating Procedures (SOPs), Master formula for manufacturing products • In-process control techniques & in-process control parameters • Analytical testing procedures • Facilities required for manufacturing of products • Stability study protocol for the product • Process validation protocol and analytical validation protocol • Training of operating personnel for technology transfer
8. Documentation • In-house guidelines • SOPs for Equipment, Process, Quality Control and Warehouse • Project Planning and management (Validation documents including VMP, Risk assessment, Impact assessment) • Development of Qualification Protocols (For Equipment & Computer System Validation) • Execution of Qualification Process (IQ, OQ, PQ) and Final Documentation (at client’s site) • Inspection / FAT at Vendors Site (For systems and equipment) • Quality Management System Documents including risk assessment documents, control systems, internal audit, CAPA, product review, management review)
9. Regulatory Support & Submission • Strategic Services • Advisory Services • Technical Assistance • Submissions for Pharma and Medical Device • Queries handling • Intellectual Property Development & Services
10. Strategic Consultancy Services • Strategic assistance in Pharma Regulatory filing • Support in Outsourcing Manufacturing or Testing Laboratories, Outsourcing BA/BE study centres • Liaison for DCGI licensing & FDA, CDSCO activities
11. Advisory Consultancy Services • cGMP compliance • GMP, GLP, QA and regulatory compliance • Compliance audits • Critical review of Dossiers • GAP Analysis/Due diligence • Schedule ‘M’ Requirements & compliance to Indian FDA norms
12. Technical Assistance • Preparation of registration dossier for drug substance and drug product • Dossier Preparation & Submissions in CTD/eCTD/ACTD format • NeeS [Non-eCTD electronic Submissions (NeeS)] formats for Health Authorities of Regulated and Semi-Regulated markets • Drug Firm Establishment Registration with US-FDA • Drug Listing in SPL [Structured Product labeling] format, Bulk Drug Listing • NDC [National Drug Code] and Electronic submission • Preparation of DMF [Drug Master Files]/ ASMF [Active Substance Master File] / CEP [Certificate of Suitability] or (CoS) / KDMF/ Technical Packages • Site Master file as per PIC/s & Local FDA requirement
13. Submission – For Drugs and Medical devices including • Drug Master File (DMF) • New Drug Application (NDA) • Abbreviated New Drug Application (ANDA) • Investigational Drug Exemption (IDE) • Fast Tracking Applications • Others – 505(b)(2) NDA, 505(j) ANDA, OTC • 510(k) Pre-Market Clearance • De Novo • Premarket submissions • Investigational New Devices (IND) • PMA Submissions • Combination Device & Drug/Biologic • Exempt Devices/513(g) submissions
14. Queries handling • Resolving regulatory queries related to filings and dossier submissions • 483 and Warning Letter Remediation • GRAS, FCNs and Food Additive Petitions • Recall Assistance • 21 CFR Part 11 • US Agent & Imports
15. Intellectual Property Development & Services • Literature review, feasibility study of your project for patentability • Assistance for developing a patentable procedure/product • Assistance in deciding to initiate/continue the development of a patented technology
16. Other Services • Selection of Ingredients (API, Excipients), Formulation Manufacturers, Packaging Materials • Procurement Assistance (for Equipment, Instruments, Raw materials, APIs) includes : o Preparation of detailed specifications and data sheets for various plants, equipment, machinery and system o Invite bids for supply of various plant equipment, machinery and systems o Preparation of detailed tender documents for supply and installation of various systems like HVAC, Water treatment and distribution, Electrical, Steam generation and distribution o Techno-commercial evaluation of the bids and recommend the best alternative o Checking & approval of vendor drawings, Checking & approval of contractors site erection drawings o Preparation of Factory Acceptance Test protocols o Expediting with vendors for timely supply of all machinery and equipment
• In licensing and Out licensing of dossiers & technologies- Requirement of long time and huge investment for research is a limitation for many pharma companies. This has led to the need of in-license and out-license services. With In-licensing you can tap the market, accelerate product sale and company growth. With Out-licensing, companies can improve usage of under-resourced assets and reduce financial risks.