Product Development
Development activities include early stage formulation and analytical development, technology transfer, scale-up, process validation and stability testing, CRO selection and clinical study design.
With pharmaceutical development, we monitor all development steps including:
API manufacture
Selection of API manufacturer ensuring supply of patent-non-infringing API, Audit of API manufacturing site, assessment of CEP or DMF.
Product Manufacturing
Qualification of finished product manufacturing sites for technology transfer, scale up, process validation and commercial supply.
Monitoring
Monitoring of preformulation and formulation trials to achieve patent-non-infringing formulation.
Analytical
Analytical method development
Clinical studies
Management of BE and Clinical studies.
Raw data collection
Raw data collection, Evaluation and Dossier preparation
We have expertise to develop below formulations
- Solid orals (Tablet, Capsules, Powder)
- Liquids
- Topical (Cream, Ointment, Gel, Liquid)
- Injectables
- Nasal Spray
- Inhaler Products
PRODUCT
DEVELOPMENT
Project Management
Our highly professional project management team is expert in clearly defining project scope and achieving targets within set deadlines. Their clear and unambiguous understanding of process flow, distribution of roles and tasks at different phases of project within various teams helps in smooth functioning of project and achieve maximum results within agreed timelines in return leading to cost effectiveness and high quality deliverance.
Project
Management
Regulatory Affairs
Our highly diligent and proactive regulatory affairs team keeps eye on ever changing legislation demands of various markets. leading to cost effectiveness and high quality deliverance.
Our First Time Right regulatory approach has played pivotal role in meeting the regulatory demands of various regions and maximizing the cost-effective use of resources. We are capable of all types of regulatory submissions (ANDA/CTD/eCTD) from semi regulated to high regulated markets ensuring fast turnaround in business.
Regulatory
Affairs
Supply Chain Management
We have experience team for supply chain management who perform below tasks
- Artwork management
- Demand Planning & Forecasting
- Pre-launch Coordination
- Launch Management
- Production Planning for own developments
- Forwarding & Shipping of raw materials and Finished Products
- Financial Control of supplies
- Supply Chain Data Analysis & Reporting
- Customer Service
- Product Seriliasaition
Supply Chain
Management
Project Management
Our highly professional project management team is expert in clearly defining project scope and achieving targets within set deadlines.
Their clear and unambiguous understanding of process flow, distribution of roles and tasks at different phases of project within various teams helps in smooth functioning of project and achieve maximum results within agreed timelines in return leading to cost effectiveness and high quality deliverance.
Regulatory Affairs
Our highly diligent and proactive regulatory affairs team keeps eye on ever changing legislation demands of various markets. leading to cost effectiveness and high quality deliverance.
Our First Time Right regulatory approach has played a pivotal role in meeting the regulatory demands of various regions and maximizing the cost-effective use of resources. We are capable of all types of regulatory submissions (ANDA/CTD/eCTD) from semi regulated to high regulated markets ensuring fast turnaround in business.
Sales and Marketing
Orbit commercial coverage extends across the entire UK, EU, Canada, ANZ and Middle East to wholesale and retail pharmacy via partner supply chain and Hospitals via tendering process.
This sales capability is experienced and highly skilled with flexibility to meet the requirements of new opportunities.
Orbit commercial coverage extends across Southeast and Africa market via Group Company
Orbit Pharmaceuticals (
www.orbitpharm.com ).
