1. Market Research

Market research is conducted to determine the viability of Drug Delivery through research conducted directly with potential customer. Market research allows a company to discover target market and get opinion and other feedback from consumer about their interest in Drug Delivery Methods. Market research is important to know the size of target market, if target market is way too small than one can decide early that it is not worth pursuing.

Market research reports has been designed to help readers navigate the medical, clinical, logistical and regulatory challenges associated with Drug Delivery. Stakeholders from sponsor organizations, CROs, and clinical trial sites are surveyed on their top techniques and innovations used when conducting a feasibility analysis, following points are considered usually:

• Their awareness of feasibility analysis service providers and the frequency of their use
• The percentage of clinical trials required for feasibility analysis.
• If analysis is typically done in-house or outsourced 
• The data sources utilized 
• Ranking of which data sources contribute to the accuracy of the estimate.

We at Hospaccx, provides hand hold to our client by delivering market and financial feasibility report on Drug Delivery. The services include:

• Key statistics on the characteristics that make up a predictive feasibility estimate.
• Impressions on the industry’s approach to feasibility analysis.
• The use of SOPs (standard operating procedures) and the accuracy of the estimations received from CROs, sites and specialized feasibility analysis firms.  
• The potential value to be gained by engaging a specialized feasibility analysis firm under specific circumstances.
• Data collection

• • Primary data collection consists data from First hand Sources such as Interviews, Questionnaire and Surveys.
  • Secondary data collection includes management of already existing data from Census reports, Magazines, Journals, Articles, Organizational records, Institutes Website etc.

 

• Assessment of the business environment of Drug Delivery

• Assessment of the performance of the local Medical Device sector

• Supply analysis of Drug Delivery devices is done to analyze the supply trends and responses of the changing market. It takes in account production cost, raw material cost, technology, labor wages etc.

• Present effective demand of Drug Delivery to know the market constraints.

• Demand forecasting by detailed study of past data is done to know the future trends of demand of Drug Delivery.

• Competitor analysis helps us analyze the strengths and weaknesses of current and potential competitors in Drug Delivery Market. 

• Market share analyses and recommendations on product mix

• Pricing and distribution of various Drug Delivery devices is planned and executed.

• Promotion and marketing strategy: An effective marketing and promotion strategy for Drug Delivery is planned to bring awareness in public regarding product.

This process will help you getting insights of the market, such as identify a real customer need, determine competitive market landscape as well as address compliance regulatory factors which can affect marketing Campaigns. Thus, we as a team ensure that your market research is up to the scratch which helps in understanding the consumer and supplier expectations.

2. Turnkey Design

Hospaccx has large network of expert and global and local suppliers. We take a complete responsibility to undertake complex and unique projects and deliver quality and timely solutions which meet industry safety standards. We as a team offer project execution in accordance with the specific requirement of Drug Delivery by our clients. We provide turnkey solutions also from green field to commissioning of facility as per international regulatory norms.

We always aim to provide complete assistance to your projects which include service as follows:

1. Manufacturing plant layout design: It is the basic step for manufacturing plant setup. Medical Device Manufacturing should be compliant with rules given by respective regulatory bodies like USFDA, CDSCO etc. Man, and Material are the primary considerations for right design of the facility. The segregation of Drug Delivery devices, its manufacturing and process flow and the use of classified area plays an important role. We have a team of experienced professionals which ensures correct decision making and smooth transitions during the audits from regulatory bodies and customers. The manufacturing layout is prepared by experts based on inputs from clients and their architects.
2. Consultation for Future Expansion: We incorporate design of your manufacturing unit in such a way that it ensures unidirectional flow of man and material. We at Hospaccx, help you in consultation for your future plans as well which accordingly change the manufacturing layout.
3. Primary packaging Layout Design: It is an important element while setting a manufacturing Unit for Drug Delivery devices. Our consultants while designing the facility give prime consideration to the Regulatory Requirement, In particular, The Cgmp requirement. The layout thus designed to ensure a smooth flow of man and material through the plant.
4. Clean room Conceptualization for Primary Packaging: We help our client conceptualize the design of clean room in the manufacturing facility as it maintains low level of Environmental pollutants such as dust, Airborne microbes, Aerosol particles and Chemical vapors.
5. Primary packaging process Validation: We at Hospaccx, guides manufacturers and validation service providers on the validation activity and documentation. Our team of expert study the Drug Delivery, their production facility and accordingly design the master plan which outlines the packaging process validation activities to be performed and timeline for the same.

Therefore, Hospaccx provide a complete solution to your Turnkey Design project for Drug Delivery devices by providing consultancy worldwide including strategic, regulatory and environmental compliance. Our team of expertise helps our client in establishing highly regulated industry to achieve compliance, efficiency and sustainable business success.

3. Marketing

Marketing involves the identification of target market customers and attracting them to avail our services and use of Products. The team of Hospaccx believes in reinventing ourselves to remain in the international Market of Medical Devices.

We at Hospaccx, provide assistance to our clients to set up international market of complete supply chain distribution, sales and marketing Network of Drug Delivery as per individual specific need and strengths.

In this service of ours we provide a complete handhold to our clients, therefore helping them to do following:

• Marketing and Sales plans, including regulatory guidance and branding of Drug Delivery.
• Planning of route to market strategies, including assessing market potential, market research and analysis, investment partners, and distributors of Drug Delivery devices.
• Development of route to market solutions for all types of Drug Delivery Devices
• Local support for market access through our wide network, which provides key local knowledge to successfully access markets.

Other Activities which we at Hospaccx aim to deliver Post Marketing Surveillance are:

1. CAPA Management: CAPA is the keystone of Quality Management System especially in Medical Device Industry, and a significant driver for Quality Improvement. We as a team help to improve Quality system by providing assistance in Improving process, procedures, organization and Business in a structured well- documented and actionable way.
2. Audit report and Compliance: There are various types of Audits conducted in order to know the status of Quality Management system, to ensure these various types of audits are conducted like those conducted by customer, USFDA, Notified Bodies, TGA or even the effective internal audits. We as a team help you with these Audit conductions.
3. Customer Complaint Handling: Word of mouth plays an important role in creating the brand image. We make sure our customer remains happy and satisfied by the services we provide. We believe in not avoiding the complaints, and take care of our customers by helping them in every possible way.

We at Hospaccx, aim to deliver these defined services with help of our expert team of Marketing and Consultants. This can help your Drug Delivery devices to get a good brand and market image, thus marketing of the product plays a key role in establishing and competing in business.

4. Certifications and Approvals

Quality management system Certification is required for every business process who need to comply with an arrangement of complex and challenging regulatory requirement. Hospaccx strategists with considerable expertise in regulatory areas required for QMS certification in implementation of medical devices. It is very essential part for a Medical device company as is considered most basic part by ISO and FDA.

We provide the following consultation certificates for manufacturers:

• US FDA 21 CFR Part 820 Quality System Regulations: This process covers the facilities and control used for the design, manufacturing, packaging, labelling, storage, installations for Drug Delivery devices.

• 21 CFR Part 210 & 211 Quality Assurance: This Process deals with manufacturing, packaging, or holding if drugs and pharmaceuticals.

• ISO 13485 Certification: It is the world acknowledged standard by the International Standards Organization for medical device quality management system. It can be used by any company involved in the transfer of medical devices. This specifies the requirements for a QMS certification. ISO 13485 certification for medical devices is a Quality management system required for regulatory purposes which is an ISO standard. Thus, we help it for getting it for your Drug Delivery devices.

• ISO 15378 Certification: This QMS certification is for packaging materials, for medicinal and pharmaceuticals products. Primary packaging materials for medicinal products which meet customers requirement as well as regulatory requirements and international standards relevant to primary packaging medicinal materials.

• ISO 9001:2015 is globally required standard to describe the requirements of a quality management system in all industries. ISO 9001:2015 provides effectual risk assurance-based Quality Management System.

Country Wise QMS certification include:

• US FDA 510k: This is a premarket approval made for FDA to signify that the device which is to be marketed is safe and effective. And also, which is substantially equivalent to the legally marketed device.

• DMF: Drug master file is a document that is prepared by the medical device makers or manufacturers in which they provide confidential information about the product to the US FDA.

• CDSCO: Central Drugs Standard Control Organization, CDSCO comes under DCGI that is Drug Controller General of India. CDSCO regulates the medical device in India, under the provisions of drugs and cosmetics acts 1940 & rules 1945. The Applications for all classes are submitted to Central Licensing Authority, where the DCGI takes the responsibility of Manufacturing, registration, import and sale of medical devices in India.

• CE marking: CE mark certification is regulatory approval for the European market. The products having a CE mark declares that the product which is to be marketed meets all the relevant European medical device directives. We’ll help to test the product, to the creation of the technical file, and resolving all the queries after completion of all the activities.

Hence, the QMS certification body and Medical Device agency professionals with in depth knowledge and technical expertise at Hospaccx can help you assist and protect your Quality System that can follow with the toughest regulatory inspection.

We therefore aim at making your Drug Delivery Device Facility to get authorized and remain to the defined standards. The certification and approvals to a particular Medical device add on to a support to its quality and therefore defining it safety for usage.

5. Project Management Consulting

Are you looking for on-site assistance to complete your New Drug Delivery device industry successfully? In this service of ours we provide the most cost- effective and expert staff on-site to execute the project most efficiently. We offer one of the effective management solutions to increase and improve the efficiency and outcome of a project in construction. Our well-trained consultants manage the project by application of their knowledge, skill and experience at every stage. During the time of construction our team assist with coordinating with vendors and help identify contractors to deliver right material at best cost. 

What does it include?

The service of project management consulting covers following 

• On-site Project Management: A qualified and trained employee is appointed to assist the working and coordination of tasks at the construction site of the venture. 
• Supervision of construction supplies and materials: A timely check and reporting of supplies is necessary to keep working and avoid shortage of materials during work. Thus, we help you in this by providing assistance in supervision of this task.
• Cost-estimation of the project: We help our clients in the process of predicting the quantity, cost and the price of the resources required by the scope of the project.
• Quality Check of the construction: We assist in inspection of the products to identify and correct defects. We ensure that the construction of the building is done as per the pre-defined norms and follows every criterion.

We always aim to deliver you the services within your budget limits for which we believe in contacting your local contractor as well. For this purpose, we have, Qualified contractor, cost estimator and construction manager who will be available during different phases of the project.  

Methodology

We at Hospaccx believe in providing the handhold till the end of your project. We work keeping in contact all the stakeholders to ensure smooth deliverance of the service. The pre-prepared project schedule including all the SOP, Safety and quality norms, construction layout etc. serves as the reference manual during this period.

Deliverable

This service aims to deliver you an assistance to manage between different vendors and contractors at your site location. We help you complete the entire project keeping in account the time, cost and quality to be up to the mark. 

6. HR and Training

For an industry to work efficiently it is important to recruit right human resource at the right place. Identifying the potential of the individuals and hiring them for a proper task has supreme value. We at hospaccx, provide a proper staff recruitment procedure and further training them to work efficiently and adopt the work culture of the Drug Delivery Industry. Our professionals rightly identify the requirement of human resource in every department and plan a proper training schedule for existing and newly recruited Industry staff.

Services and training modules included in this service are:

• Standard Operating Procedures – QA/QC/Manufacturing/Maintenance
• On the job Training for QA/QC/Shop floor employees
• Process Validation
• Installation Qualification
• Operational Qualification Method Validation
• Facility Qualification
• Purified Water validation
• Current Good Manufacturing Practices
  • • Transferring Skill on Validation
    • GLP System and testing
    • Clean Room Operations, Equipment Handling and Documentation Activities
    • Personal Behaviour in Clean areas
    • Calibration Procedures and Maintaining Records
    • Conduct Mock Audits
  • How to prepare & FACE Regulatory audits
  • WHO guideline
  • COST Improvement Projects
  • Technology Transfer
  • Statistical Process Control
  • Conducting Training and Workshops on RA/QA-QM/AD/FD/ICH/CTD/eCTD/ACTD/21CFR parts/GMP/GLP/GCP [Good Clinical Practice]-Clinical etc. with Case studies
  • Provide different training modules as per the customer specific requirements in RA, QA, cGMP, GLP, GCP, ISO, 21 CFR parts, Audits, Validations, QbD, and many more topics….
  • Provide following different types of Training programs
    • Instructor-led courses
    • In-house company trainings
    • Certificate programs
    • Distance learning courses
    • Online trainings
    • Fast-track programs

We provide training modules and complete layout for the existing and newly joined staff.

Formulate HR policies, system and procedure for specific department highlighting the area which is of great importance to that sector.

Critical evaluation of performance of each staff and mentioning the areas of improvement which increases the efficiency of delivering of services.

Thus, Hospaccx can help you with every phase of your HR requirement, management and training activities for the staff at Drug Delivery Facility.

7. Fund Raising

Do you need Monetary assistance to start your Drug Delivery device Industry? We, the team of Hospaccx are ready to help you with this and raise funds to fulfill your dreams. It is important to consider Industry’s business plans, future growth plans, future financial growths, current and past records during selecting the type of funding.

Facing financial issues in carrying out a project is normal, but stress giving. We provide complete assistance in raising funds for your Green field and Brown field Projects. By our large network of recognized and trusted bank partners and private investors who willing and are ready to invest in your project are contacted and the most suitable to the client is considered.

The process involves all the legal considerations and is documented well for future references to maintain the transparency and forthrightness.

A complete study on the background of financial status is done to get exact amount of requirement and know the future aspects.

We keep in mind few points while partnering with our investors as first determining the Philanthropy development strategy, research our fundraising prospects, Equipping the fundraiser with a tool, Prioritizing stewardship with the donor and keeping all the legal policies in mind.

Following this helps in developing trust with the client as well as the fund provider which is beneficial in long run.

We have an experienced team of financial analyzers who work efficiently in planning and designing strategies to raise funds for your dream project.

We have a defined planning and strategies services under this activity which help your company to develop a comprehensive blueprint for Organizational growth. We provide you the data-driven analysis, in-depth stakeholder engagement, and broad- ranging fundraising expertise which ultimately help you decide the best path forward. 

We not only believe in advising but can provide you, assistance in day-to-day fundraising activity.

The Fundraising initiatives designed by us can help transform the future of your Medical Devices which majorly includes the capital, endowment and comprehensive campaigns.

We therefore pair with different quantitative and qualitative methodologies to take your fundraising program forward.

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