Services:

           1. Pharmaceutical Project Management Services

          Objective

          With a clear objective of providing Regulatory Compliance, Competitive Cost and Speedy Execution, the pharmaceutical project management services of 'SUSHEN' strives to give our client a clear advantage over other. Its complete range of services is available in the fields of Sterile Processes, Medical Devices, Oral Dosage Forms, Active Pharmaceutical Ingredients and Biotechnology.

         'SUSHEN' put in great efforts in comprehending the requirements of the clients, which in turn help them in conceptualizing the project through Business Environment Study and Market Analysis, keeping in mind the technical and economical feasibility.

          The services that are offered through pharmaceutical project management services are:

• Conceptualization
• Helping the clients to finalize the project parameters especially with regards for Preparing Product portfolio & finalizing production capacity matching with quality standards to be maintained with respect to market.

• Engineering Services
• Provides services like Preparing URS, Capacity balancing, Facilities Designing, Equipments Sizing and Selection with specifications and utilities calculation for all types of pharmaceutical dosage in compliance to the cGMP standards, resulting in lower production cost with better quality.
• Provides detailed drawings for factory layout & engineering specifications with HVAC system design including detailed drawings

• Equipment & Processing Specification
• We provide the drawings for detailed engineering specifications of production equipments and HVAC
• Expertise in offering Procurement, Installation and Qualification of required equipments and machineries
• We also provide Supply of complete production equipment as well as the HVAC systems
• Reparation of these equipments, and Systems Qualification Protocol such as URS, DQ, IQ, OQ & PQ

• Technical Advisory Services
• Formulation and Development of products, preparation of Standard Operating Procedures, Quality Assurance Manuals, Operations & Maintenance Schedule, Technical Audit of Operations & Guidance in the latest methods and styles of working, in regard to recruitment of Technical Personnel

• Management Services
• Nine years of experience in providing Manufacturing Assistance, Inventory Management for raw material and work in progress, Source & Supply of Good Quality Raw Materials, Marketing Strategy Planning, Management Information Systems, Periodic Management Audit, Organizing and Implementing Training Programs, Organizing and Conducting Human Resource Development Programs
• Provides Information Technology Services like Hardware Setup Design and Supply, Software Design and Installation, Technological Up gradation.

• Regulatory Services
• Coordinate various regulatory activities for Facility Registration with various Regulatory Bodies like USFDA, EENVISA etc. with changes and updation for the following requirements
• CGMP
• Validation
• ISO Documentation
• Regulatory Affairs in India
• Operations Management
• Product Registration in various countries
• Technical Data to fulfill the local requirement

         2. International Marketing Services

         Other than the end to end solutions of Project Management Services, Sushen Medicamentos also caters to the need of International Marketing Services of various products like:

• Parenteral Packaging Material (Primary), Empty Glass Tubular Ampoules (1 to 25 ml) Clear & Amber Color, Empty Glass Molded/Tubular Vials, Oral Suspension Bottles (8, 10ml to 100ml) Clear & Amber Color
• Various types and shapes of Pharmaceutical Rubber Stoppers (13mm and 20mm), Euro disc with plastic cap, Aluminum flip-off caps/seals etc. (plain as well plastic flip-top) 
• API (Active Pharmaceutical Ingredients)
• Pharmaceutical Formulations
• Diagnostics & Medical Products
• Hospital Care Products

        3(A). Contract F&D Services

        Our contract Formulation & Development Services includes:

• Product Design and Development
• For Solid Oral Dosage forms including soluble and sustained release tablets and capsule
• For Sterile injectable formulation including LVPs and SVPs
• For Sterile NDDS formulation such as lipid emulsion, liposome etc
• GMP manufacturing of samples for clinical trials
• Preparation of required documentation
• Scale-up assistance including project design and equipment selection for designed product
• Assistance for packaging and packing material development
• Totally stability support for developed Product
• Designing of facility for Biological Products Manufacturing including Cytotoxic Formultions (Solution & Freeze Dried)

• Total Stability Studies Management
• Sample storage at various condition (Temperature & Humidity)
• Continuous recording of storage parameters
• Retrieval of sample at predefined interval
• Analysis of sample for defined parameters using validated methods.
• Structural identification and quantitation of impurities where required.
• Determination of expiration period.
• Preparation of final report and documentation required for submission.
• Providing storage facility on rental

• Facilities
• 43,000 Sq. Ft. Area & 38,000 Sq. Ft. of constructed area
• Well defined area as per the guide lines of cGMP and cGLP
• Facility will include XDR, LCMS, GC, HPLC etc
• Monograph  & Physico-chemical testing
• Micro biological testing ( including sterility and BET)
• Stability studies
• Providing working standards
• Certification of reference Standards
• Formulation development set-up
• Total Validation support
• Knowledge Management & Sharing
• Structural identification and quantification

         3(B). Contractual Analytical Services

         As in the contract Formulation & Development Services, the Contract Analytical Services of Sushen Medicamentos Includes:

• Development of specification and method of analysis
• Structural identification and quantization of impurities and polymorphism using techniques such as LC/MS/MS and X-Ray Diffraction
• Separation and purification of impurities
• Method development, optimization and validation
• Structural identification of medical specimen such as kidney stones, gall bladder stone
• Pharmaceuticals Industry
• Food Industry
• Minerals Industries

• Validation and Support Activities
• Validation Master Plan (VMP)
• Qualification Protocols like IQ, OQ, IOQ, PQ
• Validation Protocol for Utility, Systems, Processes, Cleaning, Analytical Method
• Validation Summary Reports
• Training
• Actual qualification and validation support for Equipments, Systems, Processes

• Techniques For Sample Analysis
• Physicochemical attributes
• Latest Technique Viz. UV, IR, HPLC, GC, LC/MS/MS, XRD
• Purification and preparation of working standard
• Certification of analytical reference standards via full chemical analysis

• Microbiology Studies
• Microbial Count
• Sterility Testing
• Endotoxin Testing
• Identification of microbes up to genus and species level
• Isolation, cultivation and storage of pure cultures
• Verification counting of Biological indicators
• Microbiological assays