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Neiss manufactures a widespread range of branded pharmaceutical formulation and generics products in almost all form. Our diverse therapeutic areas includes oncology, cardiovascular, gastro intestinal, ermatology, anti-infective, anti-inflammatory, anti-diabetics, pain management, antiemetic, antiulcer, nutritional products, ayurveda and nutraceuticals.

Neiss provides basket of services like Dossiers, Leaflets, and Leave behind literature (LBL), In-House Designing of Labels and Cartons. We have well documented regulatory department as well as prompt and reliable assistance for all our customers.

 

We welcome you to visit our Plants which are as per International Standards for your satisfaction. It is said that
“seeing is believing”.

 
 
 
We have ability to develop new formulations through R & D as well as by tie-ups with companies who are interested in an alliance for technology transfer for manufacturing of established products. The advantage in partnering with Neiss is our ability to produce low cost formulation of high quality with the fastest possible turnaround time.
 
We are engaged in manufacturing of varied pharmaceutical formulations like tablets which are anti-biotic, analgesic, antipyretic, anti-inflammatory, antiemetic, antiulcer etc. and Capsules, Injections, Liquids, Eye/Ear Drops and Ointments are involved along with the production of Neiss’s own range of products for domestic and international market. As a private-owned and fully independent pharmaceutical formulation company, Neiss offers flexible terms of trade and gives each customer a personal attention.
 
Thus our large scale production capacities, highly qualified production and quality control staff, state of art WHO-GMP certified manufacturing facility combines to give a perfect environment for outsourcing or contract manufacturing pharmaceutical products. All products can be supplied in the various permitted/suitable dosages and in required pack sizes in the form of small volume liquid parenterals, dry powder injectables, tablets (uncoated, sugar coated, enteric coated, film coated, chewable, lozenges, sustained release and dispersible forms), capsules (soft gel), dry syrups, liquid orals, sterile eye drops and ear drops and topical lotions for external applications.
 
We are recognized as Contract Manufacturer of pharmaceutical medicines and ayurvedic medicines that are manufactured in a modern manufacturing unit where an independent quality control department and research & development unit is maintained. The manufacturing unit includes manufacturing facilities of tablet, capsules, liquids and dry syrups (dry powder) and Injections. The factory is equipped with the most modern machinery and facilities. Highest priority is given to quality control and adequate precautions are taken to ensure flawless products and un-interrupted production.
 
Our aim is to provide Affordable, Latest and High Quality Finished Formulations with Latest and Hygienic Packaging, which will benefit the end customer. Our main customers are our partners involved in distribution of our products. We ensure that we enjoy lifetime patronage of our Distributors/ Partners/ Agents.
 
Kindly contact us for your requirements to enable us to give you our best rates. We offer our products on third party basis and under neutral label for export.
 
We welcome you to visit our Plant which is being made as per International Standards for your satisfaction. It is said that Seeing is Believing.

 

Query related to contract manufacturing
 
   
 

Neiss provides a full range of contract services from early clinical development through commercial manufacturing and packaging for sterile pharmaceutical and biotech products. Our expertise and experience cover a wide range of processes and sterile dosage forms, allowing Neiss to bring innovation in design, development, technology, validation and regulatory science to each project.

 

Quality assurance is responsible for overseeing application of all standard operating procedures, for self-inspection programs, internal and external audits, follow-up of stability programs and other activities in its domain, such as validation.

When it comes to outsourcing your drug development project, you need a partner whom you can count on. Neiss possess diverse therapeutic expertise and a comprehensive scope of clinical services. Our diverse therapeutic areas includes oncology, cardiovascular, gastro intestinal, dermatology, anti-infective, anti-inflammatory, anti-diabetics, pain management, antiemetic, antiulcer, nutritional products, ayurveda and nutraceuticals.

Our clinical research contract management is based on your requirements, budget and timeline. Understanding your exact requirement is our forte and your advantage.

Pharma Services
     
 

Our systematic process begins with creating timeline for the project followed by in-depth resource requirement plan. Further, we assign dedicated resources to you, and prepare a customized management plan for the project. For every customer, we develop customized solutions that can meet the challenges of the project.

 
 

Our ever lasting relationship with various stakeholders and our hands on experience in managing the contract management in clinical research guarantees the high efficiency with in allocated resources.

 
 

We work on all aspects of Clinical Drug Development including Clinical trials, Clinical laboratory, Data management, Bioequivalence/Bioavailability studies and are well versed with the Pharmaceutical R & D, Biotech R&D, CRO, and Regulatory environment in India.

 
 

Our services in the Contract Research Management include:

 
 

Pre-clinical services:

 
 

Toxicology study:

 
 
  • Acute toxicology studies
  • Repeated dose toxicity studies
  • Reproduction toxicity studies
  • Special toxicity studies
 
 
   Acute Dermal Irritation Test (ADIT)
 Mucous membrane Irritation Test (MMIT)
 Guinea Pig Maximization Test (GPMT)
 Toxicokinetic Study
 
 

Development of various animal models on the following conditions

 
 
  • Hyperlipidemia
  • Diabetes
  • Gallstone
  • Hypertension
  • Laxative
  • Analgesic
 
 

Surgical models to derive Pharmacokinetic & Pharmacodynamic data

 
 
  • Jugular vein
  • Carotid artery
  • Middle cerebral artery
 
 

Pharmacopial Tests

 
 
  • Various Potency/ Bioassay tests for biological products
  • Undue Toxicity Test
  • Pyrogen Test
 
 

Clinical Research (Phase II – III)

 
 

We offer complete package for conducting phase II to III. Our team of researchers has experience in various therapeutic areas:

 
 

Medical writing and protocol development:

 
 
  • Design of Investigator’s Brochure
  • Study Protocol Development
  • Screening form & CRF Designing
  • Expert review & reports of Safety data
  • Statistical analysis report
  • Regulatory Support
 
 

Site Development & Management:

 
 
  • Site Identification & contracts with investigator
  • Investigator’s training programs
  • Randomization, packaging, coding & labeling of Investigational Products
  • Site Initiation
  • Site Supplies
  • Medical monitoring & query management
  • Study close-out
 
 

Project Management & Site Monitoring:

 
 
  • Clinical Development plan
  • Steering committee meetings
  • Training & Development
  • Quality Systems Implementation
  • GCP Audits at Investigators Site
  • SOP Management
  • Clean & locked data & corrective measures management
 
 

Bioavailability / Bioequivalence Services:

 
 
  • Protocol development & Study designing
  • Conduct of a range of BA / BE studies:
 
 
   Single Dose Fasting & / or fed state
 Multiple Dose / Steady state studies Fasting & / or fed state
 Dose proportionality studies
 Therapeutic equivalence studies
 Open-ended / blinded studies
 Bioequivalence assessment of generic dosage form
 
 

Bio-analytical Facility

 
 
  • Proactive development & validation of new assay methods
  • Adaptation & Revalidation of Sponsor’s assay method
  • Biological sample analysis of drugs & metabolites for pre-clinical
 
 

Safety & efficacy are our prime motto. This is reflected in our compliance to applicable regulatory requirements and GCP.

 
     
  Query related to contract research  
 
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