Cozeal Healthcare believes in building Partnerships anddelivering a COMPLETE SOURCING & DOSSIER PREPARATION, BE STUDIES PREPARATION& SUBMISSION services in an efficient manner. We give our 100% in yielding the best services to our partners.
Cozeal serves its customers all around the globe to get products on contract basis and Loan licensing& BE Studies and Dossier preparation of major categories of drugs like Multivitamins, Anti-Cancer, Anti-Infective, Cardiovascular, Cephalosporin, Erectile Dysfunction, Antifungal, Antiretroviral, Anti-Asthmatic, Ophthalmic, Antihistamines, Anti-Ulcerative, Anti-Malarial, Anti-Inflammatory, Antibiotics, Anti-Diabetic, etc.
Cozeal Healthcare is extensively engaged in providing best Contract manufacturing services and documentation (dossier) preparation services all over the world. We help the clients to cater best services from the factories without compromising with the quality of the medicines that comply with global standards.
The services we provide is not just about providing manufacturing services but giving them the best experience of complete supply of the product till the destination. We give emphasis on high quality standards and innovative technologies.
We provide our customers not only competitive pricing but also regulatory compliance, flexibility on the production capability and on time delivery. Overall our services complies with good manufacturing practice for our client and also from Food and Drug Administration. We have several tie ups with WHO GMP, cGMP, EU-GMP, USFDA & plants in India.
Our Regulatory team has a rich experience of providing services across therapeutic segments (including animal health and herbal products dossiers) and has registered more than 5000 products in over 100 countries for Pharmaceutical Industry worldwide.
Our Regulatory team has members that are extremely professional and highly experienced in the same field. They are sure to lend a helping hand when you need and make sure that all your work is done in the right way.
Cozeal is here to help you in fulfilling all your manufacturing needs. We are a specialist in offering contract services all over the world. You can take care of your customers and market, while we take care of the products and it’s registration.
Writing Dossier in required format for registering the products in worldwide markets like EU, USA and ROW countries in CTD format and as per country specific guidelines for any dosage form.
Drug Master File (DMF) compilation for open and closed part,
We provide support in conducting Structural elucidation of substances, impurity profiling and related validations and stability studies.
Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
Expert reports on Quality, Pre-clinical and Clinical
We prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
We ensure Periodic Safety Update Report (PSUR) preparation.
Mutual Recognition Procedure documents preparation.
We provide support in responding to queries from Regulatory Agencies, timely submission of all types of variations, including change of ownership, change of manufacturing sites and new indications.
We review of dossiers prepared by Indian companies for registering products in EU by our European counterpart.
Total development of product from lab scale to pilot plant scale to actual production scale for Drug Substance and Drug product.
We provide analytical support in analytical method development / validation, Routine analyses of products by HPLC/GC/MS etc., Product characterization and Impurity profiling at our company .
Complete stability programme management service is provided as per ICH guidelines / special requirements in a cGMP and GLP compliant environment at our company.
Business Development and Business consultancy is provided on various aspects related to Product Development and Contract Manufacturing both for Domestic and Export markets.
Monitoring and liaisoning with the CRO’s for PV or PhV (Pharmacovigilance Study Report) & BA/BE (Bioavailability /Bioequivalence) Studies Reports
Cozeal is a highly committed and top class team whose whole and sole mission is to provide you a service of ethical standards. The team also ensures that we complete your work on time. Also it is our priority that the process is speedy because in today’s world ‘time’ is a very precious factor.
We play the role of a mediator between the Regulatory bodies and your company.
We also help you in all the ‘Before’ and ‘After’ processes of the product launch.
We provide you with all the help you need. We also ensure that we are there for you whenever you need us. Our support group gives you the backup you need, whenever and wherever you want.
The Mission of our team is that we make working with us an amazing experience. We are dedicated towards providing the best of best service to you.
We provide outstanding products and unsurpassed service that gives premium value to our customers
We give you the commitment that we as a company will make a positive difference in your life.
We believe in working hard and also working smart. We make optimum use of our resources to give you the results you need.
It is our mission to be the worlds most respected brand. To do so we have established a team that provides an exceptional service to our customers.