TRANSFORMING
IDEAS INTO
INNOVATIONS
NV Remedies offers a system of complex project management, including recommendations at a step of the search and estimation of the idea to a step «ready-to-start production facilities» and subsequent follow-up. Pharmaceutical engineering is involved in the conception, pharmaceutical development, design, scale-up, manufacturing, labeling and packaging processes in the conversion of chemical and biological materials into valuable pharmaceuticals.
PHARMACEUTICAL
ENGINEERING
AND TECHNOLOGY TRANSFER
The key to success is in the effective management of the project and updating the information about pharmaceutical engineering and closely related industries. Methods of technology transfer refer to the processes of successful progress from drug discovery development with application of flexible logic models, up to the bioequivalence and/or clinical trials and ultimately full-scale commercialization.
Scope includes review of the acceptability of the stability study of the finished product, determination of action plan in case of failure of stability studies.
Engineers provide technical support to enable technology transfer and address technical issues with local manufacturing groups. These groups are also involved in process engineering and work to improve and expand existing pharmaceutical processing systems. Our capabilities in technology transfer projects include API development and manufacturing, formulation development, analytical development and testing services, and stability.
Scope includes review of the acceptability of the stability study of the finished product, determination of action plan in case of failure of stability studies.
Engineers provide technical support to enable technology transfer and address technical issues with local manufacturing groups. These groups are also involved in process engineering and work to improve and expand existing pharmaceutical processing systems. Our capabilities in technology transfer projects include API development and manufacturing, formulation development, analytical development and testing services, and stability.
Research and Development is the driver of innovation and leadership
This is the way to experience future growth and develop new products or processes. NV Remedies team of experts has built an impressive track record of successful projects and constantly work to bring out products with appropriate technology and features to meet the changing customer needs.
The scope of R&D services includes generation of patent landscapes for molecules under development, identification of patent non-infringing approaches for patented molecules, opportunities identified as Para-IV candidates, and increased rate of Bioequivalence success. The development reports provided are based on US FDA, EU requirements (ICH Q8/QBD).
Company’s performance edge is based on offering Quality-By-Design (QbD) concepts at all stages of formulation development. The Design of Experiments (DOE) along with relevant time scale and risk assessment helps to develop the strategy for further experimentation.
The scope of R&D services includes generation of patent landscapes for molecules under development, identification of patent non-infringing approaches for patented molecules, opportunities identified as Para-IV candidates, and increased rate of Bioequivalence success. The development reports provided are based on US FDA, EU requirements (ICH Q8/QBD).
Company’s performance edge is based on offering Quality-By-Design (QbD) concepts at all stages of formulation development. The Design of Experiments (DOE) along with relevant time scale and risk assessment helps to develop the strategy for further experimentation.
RESEARCH
AND
DEVELOPMENT
NV Remedies has a wide R&D experience in
Dosage forms handled
Tablet
Immediate-release, Sustained-release, Delayed-release, Film-coated, Orally disintegrating
Capsule
Powder, Granule Filling
Pelletization
Into Tablet or Capsule Filling
Powder in Bottle
Liquid
Solution, Suspension, Emulsion
Semi Solid
Cream, Ointment, Gel, Lotion
Parenteral
Injections
- Solution
- Lyophilization
- Emulsion based
- Nano Technology based
Product technologies handled
- Gastro retentive/protective technologies
- Matrix based modified release technology
- Reservoir based modified release technology
- Osmotic drug delivery systems
- Taste masking technologies
- Finalizing the filing strategies in the designated markets
- Helping technology development companies to hold intellectual property without the need for manufacturing and testing units
- Special expertise to carry out sterile filter validation study
Process technologies handled
- Lab scale stability studies & stress stability studies
- Identifying and mitigating the risks associated with BE studies by carrying out extensive in-vitro studies
- Analytical method development/Validation
- Technology transfer to the manufacturing site
REGULATORY
SUPPORT
NV Remedies provides assistance to pharmaceutical companies to achieve their priority regulatory milestones, to ensure the effective movement of the product through the regulatory process. The company provides data monitoring and analyzes it in the appropriate context; and generates a meaningful output with the designation of the risks and opportunities for the client’s strategy on the issue of regulation. All the process of the regulatory support is based on the business needs and is linked to the decisions and actions.
- Defining regulatory strategy to identify & mitigate potential challenges at early stage of development so as to obtain speedy approval for EU, USA and Emerging Markets
- Development of strategies for Clinical Trial Application, existing dossier suitability to new market (Gap analysis and solution), define critical regulatory information and strategic plans for drug development based on prevailing Regulatory Guidelines
- Scale up Non-CTD to CTD dossiers and from EU/US CTD to Regional CTD format, preparation of regulatory framework and Roadmap for approval
Extensive expertise and experience allow us offer the following range of servies
The company offers full cooperation and assistance in the process of preparing CTD format on all modules, which are intended to be common for all regions. We provide regulatory support to match regulatory requirements in stringent regulations territories, such as EU, USA, Canada, as well as Emerging Markets, for the manufacturing and registration of pharmaceutical products from generic drugs to biotech products including Bioequivalence studies and clinical trials.
- Regulatory strategy
- Defining regulatory strategy to identify & mitigate potential challenges at early stage of development so as to obtain speedy approval for EU, USA and Emerging Markets
- Defining Clinical (CT/BABE, Published information, RLD/Comparator suggestion), Non-clinical (pre-clinical/Tox data) and Technical requirements (API and Drug Product specification & advise, stability data, evaluation and proposed shelf life,) and support to develop quality product dossier
- Preparing Country Specific Product Strategy at the time of Product development
- Development of strategies for Clinical Trial Application, existing dossier suitability to new market (Gap analysis and solution), define critical regulatory information and strategic plans for drug development based on prevailing Regulatory Guidelines, analyzing fast track approval possibility, specifying Regulatory Process, Timelines for approval and applicable fees, Relevant precedents based on earlier opinions/ queries, define risks/ regulatory barriers (i.e. WHO-GMP, COPP, Price Approval, Site Inspection, Approved BE Center, Co-validation at out of India,) and mitigation plan, preparation of Global Submission strategy
- Scale up Non-CTD to CTD dossiers and from EU/US CTD to Regional CTD format, preparation of regulatory framework and Roadmap for approval
- Regulatory tools and medical writing
- Check list of documents in line with prevalent regulatory submission guidelines for Marketing Authorization Application across Globe
- Global Regulatory Information Sheet covering Critical Parameters i.e. Batch Size & Stability data requirements, Timeframe for Approval, Types of submission, Applicable fees and major regulations
- Investigational Medicinal Product Dossier (IMPD)
- Submission modules (CTD Modules 2.4, 2.5, 2.6, 2.7, Module 4 & Module 5)
- Patient Information Leaflet and SmPC
- Expert reports
- Due diligence and/or creation of technical dossier in various CTD/National formats
- Dossier evaluation for Health Agency’s acceptability
- Technical Specification evaluation as per local pharmacopoeia
- Third Party or Contract manufactured data evaluation
- Gap analysis and proposed solutions
- Labeling Advise
- Support in submission to Health Authorities
- Dossier submission -Electronic / Paper technical data preparation with local forms/application and actual submission to respective Health Authority.
- Labeling Management -Preparation of draft Labels for Primary and Secondary Packaging Materials, Patient Information Leaflet & SmPC. Side by Side comparison of Labels in reference to innovator
- Local Translation -We support translation of dossier as well as labeling content in multiple languages
- Agency Meetings if any -Arranging meeting schedule with Health Authority for technical discussion.
- Query response -Preparation of query response based on Health Authority’s query and timely submission to our client / authority
- Product life cycle management
- Product variation / amendment application — Defining the type of variation (Type I or Type II for EU, PAS, CBE 30 or APR for USA), reviewing technical data, preparation of application and submission to health authority
- Product Renewal or Re-registration — Suggesting/filing for renewal / re-registration application, well in advance to avoid de-registration of the product
- Renewal of manufacturing Site GMP — Timely preparation and submission of renewal application for Site GMP
- Annual Product Review submission — Preparation and submission of Annual Product Review to health authority
NV Remedies offers validation and compliance services to the pharmaceutical and related industries, including audit object, assess the client’s current state of production to meet the actual requirements of GxP quality standards. Facility Audits and Validation Service include checking of equipment qualification, technical and engineering systems, which should be verified according to structured and documented procedures agreed with the client.
- Validation of the strategy and writing validation (master) plans
- Management of validation services, including the validation of purification technologies
- Provision of compliance and validation advice at the early stage of projects
Validation services
The company offers a comprehensive suite of validation services of production and design facilities approved by validation experts that fully meet international standards, such as checking and preparation of documentation on possible process deviations and/or discrepancies.
The audit activities are focused on risk analysis and what is critical to the quality of the final product. The company’s specialists provide recommendations for the necessary changes or alternative solutions needed to address the identified problems, such as development of a balanced certification strategy and validation master plan.
The audit activities are focused on risk analysis and what is critical to the quality of the final product. The company’s specialists provide recommendations for the necessary changes or alternative solutions needed to address the identified problems, such as development of a balanced certification strategy and validation master plan.
FACILITY AUDITS AND
VALIDATION SERVICES FOR GXP
CERTIFICATION
- Validation of the strategy and writing validation (master) plans;
- Management of validation services, including the validation of purification technologies;
- Production validation and testing the characteristics of products;
- Provision of compliance and validation advice at the early stage of projects;
- Quality assurance and project management services;
- Determining the optimal characteristics of production, storage and transportation facilities;
- Risk assessment (RA) in accordance with FMEA, FTA, HACCP methods;
- Assistance in implementation of effective quality systems;
- Project management services,
- Development of a validation and qualification plan based on DQ / IQ / OQ / PQ qualification protocols;
- Certification tests;
- Preparation, implementation and documentation of acceptance tests;
- Review of validation documentation packages;
- The resolution of imposed regulatory actions related to compliance and validation;
- Staff training for GMP compliance;
- Audit of suppliers (on request);
- Preparation of all necessary documentation according to the international requirements;
- Creation of individual staff training plans related to certification and validation of technology;
- Consulting in methods and procedures of maintaining cleanliness of production equipment.
GXP STAFF TRAINING
AND COACHING
Peter Senge
described learning organizations as
«…organizations where people continually expand their capacity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together.»
Seeing the «whole» as regards GxP is imperative and will keep organization on track with existing rules as well as emerging ones.
Companies implementing GxP are performing a regulated process that is most likely linked to a predicate rule or guidance and should be covered by policy and/or specific documented procedures (a.k.a. SOPs). NV Remedies has an extensive expertise and provides services for qualified staff recruitment, training and coaching. The advantages of cooperation include
Below is the tentative list of general courses offered by the company. Extended programs and individualized programs shall be considered based on customer’s requests and needs.
- Customization to fit individual customer’s needs
- Building-in customer’s schedule
- Optimization of group size and number of coachers
- Staff certification
Below is the tentative list of general courses offered by the company. Extended programs and individualized programs shall be considered based on customer’s requests and needs.
- Quality policy
- Data Integrity
- Environment, Health & Safety
- Quality Management System
- Validation & Qualification
- Training for Clean Room Operations, Equipment Handling and Documentation Activities.
- Procedures for Operation, Cleaning and Preventive Maintenance.
- Procedures for Environment Monitoring.
- Procedures for Calibration of Master Instruments and Process Instruments.
- Calibration Schedules –Equipment wise.
- Procedures for Operation, Cleaning, Sterilization, Disinfection, Sanitization & Monitoring.
- Procedures for Gowning & De-Gowning.
- Procedures for Personnel Hygiene Monitoring and control.
- Procedures for Area Monitoring and control.
- GLP System and testing.
- Review of Instrument Qualification Protocols & Monitoring of Commissioning Activities.
- Instrument Calibration Schedule and Monitoring of Calibration Activities.
- Procedures for Testing Activities of Water, Nitrogen, Raw Materials, In Process Material, Packing Material and Finished Products.
- Procedures for Testing Activities of MLT/ Bio burden in Purified Water, WFI, Pure steam, Raw Materials & Product. Procedures for Testing Activities of BET in Purified Water, WFI, Pure Steam, Raw Materials and Product.
- Procedures for Testing Activities of Product Sterility Testing. Procedures of Media Preparation, Sterilization, Plate Preparation, Exposure Activities.
- Procedures of Culture Suspension Activities & Organism Identification.
- Standard Test Procedures, General Procedures, Stability Specifications and Other Miscellaneous Test Procedures.
- Procedures of Biological Indicator Qualification & Handling. Procedures of Incubation & Inspection Activities. Concerned Persons, Monitoring of Execution and Review of Reports.
- Procedures for Goods Receiving, Storage, Segregation, Sampling, Dispensing and Issuance.
- Procedures for Monitoring /recording of Storage condition.
- Procedures for storage of Finished Goods.
- Preventive Maintenance of Process Equipment
- Preventive Maintenance of Facility
- Preventive Maintenance of Utilities (Clean & Black)
- Calibration of Equipment
- Engineering SOPs
LET'S CREATE
TOGETHER!
TOGETHER!
