OINTMENTS

Market Research

Market research is usually considered laborious and monotonous. A proper market research promotes targeted marketing of the new Ointment in the market. The process also involves gathering, recording and analyzing information about customer, competitors and market. We at Hospaccx, conduct market research on behalf of our clients/ partners specifically as per their need and requirement based on both the primary and secondary data. This involves both the desk and the field work by our well qualified local team across the globe.

Various Services included in this are:

Preliminary assessment and study of Ointment, client’s requirement, market and purpose of research

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 Ointment

Assessment of the performance of the local pharmaceutical sector for Ointment

Supply analysis of Ointment 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 Ointment to know the market constraints.

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

Competitor analysis helps us analyze the strengths and weaknesses of current and potential competitors in Ointment Market of Pharmaceuticals.

Market share analyses and recommendations on product mix.

Pricing and distribution of various Ointment is planned and executed

Promotion and marketing strategy: An effective marketing and promotion strategy for Ointment are 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 patient, physicians and pharmacist expectations and habits.

By providing this service we aim to deliver a detailed and transparent picture of Ointment market in Pharmaceutical Industry. By conducting various interviews, surveys and gathering secondary information customer needs can be easily identified. Hospaccx, asses the market and provide competitive analysis reports which helps our client in predicting future demand and accordingly making strategies.

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 Ointment by our clients. We provide turnkey solutions also from green field to commissioning of facility as per international regulatory norms like USFDA, TGA, UKMHRA, WHO GMP, ISO 9000, MCA, cGMP, MHRA, EU and PICs, etc. We work in different combination of responsibilities depending on customer requirements. It can be an EPC (Engineering, Procurement & Construction) contract including complete construction of infrastructure and supply and commissioning of production machinery and systems or it can be a Procurement Management contract.

The services included in this:

Advisory and Consulting

Feasibility Analysis of Ointment, comprising of
1. Market Feasibility Study
2. Technical Feasibility Study
3. Financial Feasibility Study
Technology Sourcing and Transfer
Technical Assessment and Due Diligence
cGMP audit of existing and / or new facilities to confirm their compliance with the EU GMP, UK MHARA, US FDA, PIC/s, MCC. ANVISA, WHO etc. Recommendations of measures to upgrade existing facilities to such International standards.

Site Master Planning. Sequential approach to develop the Site Master Plan:

Project Objective covering the different Ointment planned to be manufactured with the projected capacities along with the desired approvals/compliances (considering the target market) and the timelines.
Strategic Planning (Phase-out Plan)
Number of Building and Blocks envisage
Site Analysis
Regulatory Compliance
Location and Orientation of the buildings and blocks
Facilities and Amenities Planning
Building Floor Levels
Land Scaping

Concept Engineering
Design and Engineering
Procurement Assistance
Project and Construction Management
Documentation

Qualification and Validation
1. Project planning and Management

Validation documents, Validation Master Plan (VMP), Equipment Validation Plan (EVP), Risk Assessment (RA), and Impact Assessment (IA).
Master Validation / Qualification Schedule.

1. Qualification Protocols – Equipment and Computer System Validation

Design Qualification
- - Review of User Requirement Specification (URS) considering the GMP Risk Analysis
  - Review of Functional Design Specification (FDS) of equipment for establishing traceability with URS and GMP Risk Analysis
  - Prepare Design Qualification protocol and establish qualification for each equipment
Co-ordinate with vendors/Prepare Factory and Site Acceptance Testing (FAT and SAT) protocols for equipment
Co-ordinate with vendors/Prepare Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Protocols of the said equipment and systems
Preparation/ Review of Area/ Facility Qualification Protocols
Preparation of Qualification Protocols (SRS, RA, PVP, ERES, HLRA, IQ, OQ, PQ) for PLC, HMI, SCADA, Camera System in Compliances with GAMP 5 and 21 CFR Part 11
Preparation of Product Microbial Limit Test (MLT), BET, Bio-Burden, & Sterility Method Validation Protocols
Preparation of Analytical Method Validation/ Verification Protocols
Preparation of Vendor Qualification Protocols for Raw & Packing Materials
Preparation of Process Validation Protocols by considering Critical Process parameters, Critical Quality Attributes as per Process Development requirements

1. Execution of Qualification Process and final documentation at client’s site.
2. Inspection / FAT at Vendor’s site

Standard Operating Procedures

1. Process

Preparation of Procedures for Operation, Cleaning and Preventive Maintenance
Preparation of Procedures for Environment Monitoring
Preparation of Procedures for Calibration of Master Instruments and Process Instruments
Preparation of Calibration Schedules – Equipment wise
Preparation of procedures for Operation, Cleaning, Sterilization, Disinfection, Sanitization & Monitoring
Preparation of procedures for Gowning & De-Gowning
Preparation of procedures for Personnel Hygiene Monitoring and control
Preparation of procedures for Area Monitoring and control

1. Quality Control

Review of Instrument Qualification Protocols & Monitoring of Commissioning Activities
Preparation of Instrument Calibration Schedule and Monitoring of Calibration Activities
Preparation of Procedures for Testing Activities of Water, Nitrogen, Raw Materials, In Process Material, Packing Material and Finished Products
Preparation of Procedures for Testing Activities of MLT/ Bio burden in Purified Water, WFI, Pure steam, Raw Materials & Product
Preparation of Procedures for Testing Activities of BET in Purified Water, WFI, Pure Steam, Raw Materials and Product
Preparation of Procedures for Testing Activities of Product Sterility Testing
Preparation of Procedures of Media Preparation, Sterilization, Plate Preparation, Exposure Activities
Preparation of Procedures of Culture Suspension Activities & Organism Identification
Preparation of Standard Test Procedures, General Procedures, Stability Specifications and Other Miscellaneous Test Procedures
Preparation of Procedures of Biological Indicator Qualification & Handling
Preparation of Procedures of Incubation & Inspection Activities
Training to Concerned Persons, Monitoring of Execution and Review of Reports
Preparation and Develop the Disinfectants Validation Protocols, Monitoring the Execution and Review the Reports

1. Warehouse

Preparation of Procedures for Goods Receiving, Storage, Segregation, Sampling, Dispensing and Issuance
Preparation of Procedures for Monitoring /recording of Storage condition
Preparation of Procedures for storage of Finished Goods

Quality Management System – QMS

Master Project Quality Plan
Project Quality Risk Assessment documents
Equipment Quality Risk Assessment documents
Process Quality Risk Assessment documents
Quality Impact Assessment documents for assessing equipment as Direct, Indirect and No Impact on Quality
Quality Manual & Training Manuals
Site Master File
Change Control System
Deviation Control System
Incident Control System
Out of Specification System
Market Complaints and Product Recall Handling System
Internal Audit / Self Inspection
Manufacturing Activities Monitoring System
Analytical Assurance & Monitoring System
Microbiology Assurance monitoring system
Engineering Assurance Monitoring System
Documentation System
CAPA System
Annual Product Review System
Management Review System
GLP System
Calibration Policy and Master Calibration Schedule
Development of Training Schedule for all Plant Personnel

Regulatory Compliance Support

Strategic Services

Strategic assistance in Pharma Regulatory filing
Support in Outsourcing Manufacturing or Testing Laboratories for Clients
Support in Outsourcing BA/BE study centers

Advisory Services

cGMP (current Good Manufacturing Practice) compliance
Advisory services to queries pertaining to pharma GMP, GLP, QA and regulatory affairs
Compliance audits as per current and updated statutory pharma regulations
Critical Review of Dossiers
GAP Analysis/Due diligence

Technical Assistance

Preparation of Ointment Substance and Ointment product registration dossier
Dossier Preparation & Submissions in CTD [(Electronic Common Technical Document (drug registration)]/eCTD, ACTD [Asian Common Technical Dossier]
NeeS [Non-eCTD electronic Submissions (NeeS)] formats to different Health Authorities of Regulated and Semi-Regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, MCC-SA, ANVISA, ASEAN countries and ROW markets including Indian DCGI and CDSCO
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

Training and Development

- 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 Behavior 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 at Hospaccx, thus provide a complete handhold from planning to manufacturing and training of individual involved in Ointment industry. From advising and consulting to training and development, we aim at providing assistance at every phase of your project for Ointment in Pharmaceuticals.

3.Marketing

Marketing involves the identification of target market customers and attracting them to avail our services and use of Ointment. The team of Hospaccx believes in reinventing ourselves to remain in the international Pharmaceutical market. We help you find solution to every business problem.

We have a large network of representatives from different field such as service providers, marketing, sales, distribution and business development partners of worldwide pharmaceutical producers of Biological and Biosimilar, Biotechnological, Original and Generic Medicines, APIs, Food Supplements, Cosmeceuticals, Nutraceuticals and 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 Ointment of Pharmaceuticals 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 Ointment.
Planning of route to market strategies, including assessing market potential, market research and analysis, investment partners, and distributors of Ointment.
Development of route to market solutions for all types of Ointment products.
Local support for market access through our wide network, which provides key local knowledge to successfully access markets.
Facilitation or support in Marketing, Distribution and Sales of non-registered Ointment (medicines registered at country of origin but not registered at country of importation) if it is a niche, orphan or product in current shortage on specific markets.
Representation services.
In-license and out-license business models.
Tender team dedicated to complete tender analysis, participation and post-tender activities (sales, marketing and promotion), either through our own specialist team or through network of local partners.
Mergers and Acquisitions: Either you are about to sell existing MA, part of your business or whole business, or you are searching for a partnership or you would like to have transfer of existing MA, to acquire in total or in shares of already developed pharma business – we are always ready to receive your request, evaluate it and propose different models and offers for your evaluation.
Technology transfer

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

Certifications and Approvals

Pharmaceutical products usually require various types of certification and approvals right from its manufacturing to the distribution in the market. We as a team help you get the certification and approvals of the Ointment products so as to get legal authorization for the product.

Various handhold services we provide under this are as follows:

Dossier preparation (CTD, eCTD) for Ointments
Consultation with regulatory authorities for scientific advice
Briefing documentation for scientific advice procedures
Product Information texts
Risk management plans (RMP)
Handling of assessment reports
Clinical trial planning, management, evaluation and interpretation of results
Systematic literature searches
PSURs
DSURs
Feasibility assessments and gap analysis for project assessments
Due diligence for in-Licensing candidates
Identification of qualified service partners, key opinion leaders and scientific experts
Clinical evaluation of Ointment
Medical Writing

Another important part for Ointment product is its commercialization. We have an experienced group of international teams who assist our clients and partners with regulatory strategy and advice.

Regulatory Strategy

Evaluate technical data (chemistry/manufacturing, pre-clinical, and clinical) to help determine the appropriate regulatory procedure and legal status of Ointment.
Actively consult with regulatory authorities for scientific advice (protocol assistance for orphan drugs)
Arrange and manage scientific advice meetings with regulatory authorities
Propose optimal filing and submission strategies
Establish frequent contact with regulatory authorities to facilitate compliance

Regulatory Management and Implementation

Clinical trial applications
Dossier preparation (CTD, eCTD)
Translation services
Submission processes
Liaison with health authorities
Marketing authorization applications, procedural management, and marketing authorization holder ship
Post-approval maintenance
Variations, renewals, pharmacovigilance, and PSURs
PDEs
Technical expert services
Pre and post marketing pharmacovigilance project management through local pharmacovigilance qualified person.

QM systems and Certifications

Achieving an optimal quality system, which fulfils country specific requirements and fits to your company internal strategy and processes, is mandatory for successfully achieving the required licenses and certifications and enhancing a high internal compliance for Ointment. Our highly experienced and qualified team, involving local expertise where necessary, supports you with any service that will benefit your existing or intended system. Our in-house international auditing team, assists in all aspects of auditing. Our services include but not limited to:

Preparation of International regulatory audits
Training for systems and documentation for all levels
Validation of Systems, Process, Equipment, Cleaning
GLP audits for safety, pharmacology, toxicology, and human and animal bioanalytical studies, as well as other studies conducted under GLP
Experienced and frequently trained audit team with local reliable support
Vendor Qualification Audits
Compilation and submission of applications for the required certification and licenses including follow up with the authorities
Hand holding our partners / clients throughout the process from start of discussion till the final achievement of Compliance and Certifications like US FDA, MHARA, EU / EDQM, PIC/s, WHO-GMP, ANVISA, TGA, MCC, ICH, Canada, JFDA and others.
Mock inspections and support during inspection preparation
Preparation of Inspections (Mock Audits)
Support during inspection
Support during follow up of authority inspections until granting of the intended certification(s) and license(s)

We therefore aim at making your Ointment company and product to get authorized and remain to the defined standards. The certification and approvals to a particular service or product add on to a support to its quality and therefore defining it safety for usage.

Our experts by their in-depth knowledge of all the certification and approvals protocols helps our client to get the same easily and continue the further procedures to fulfill their goals.

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 Ointment 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 Behavior 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 Ointment industry.

Fund Raising

Do you need Monetary assistance to start your Ointment 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 Pharmaceutical which majorly includes the capital, endowment and comprehensive campaigns.

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

Project Management Consulting

Are you looking for on-site assistance to complete your New project for Ointment Pharmaceutical 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.