We are a global pharmaceutical regulatory techno commercial consultancy services. We assist pharmaceutical and life sciences industries for both human and veterinary to register their products and access the rapidly growing diverse markets throughout the world. We provide regulatory services for dossier submissions such as DMF / CTDs-ACTD / ANDA / Validations / CGMP / GLP / PSUR / BA-BE Studies.
We have been assisting regulatory services for pharmaceutical and life sciences industries for different countries like US, Europe Region and ROW countries like Australia, New Zealand and Asia – Singapore, Malaysia, Indonesia, Thailand, The Philippines, Vietnam, Iran , Egypt, Israel, African Countries, Russia, Taiwan, Hong Kong, South Korea . We are capable to guide for the making of documentations like Tech pack , DMF’s for API’s and CTD’s/ACTD’s , eCTD’s, ANDA’s for Formulations and combinations with Tech Transfer for API’s , Biotechnology, Bio similar products, Transdermal and Formulation solid dossiers, capsule, injectables, spray, cream etc with 3 plant validation batches along with documentation.
Our mission is to inspire the organizations to work more efficiently and create greater choice in the domain of Regulatory services for the benefit of all of our associates.
To be a India’s best provider for the Regulatory solutions –A business that has a positive impact on millions of people every day, we are conscious for our Global role in the Corporate Pharma World.
We provide best regulatory solutions as to become best provider for the pharmaceutical and regulatory solutions – We are committed to provide best customer services in terms of quality and current extensive knowledge in it’s fields of expertise.
We have an integrated knowledge of the Directives, Regulations, Policies and Guidelines. We find the most Meaningful and Practical solutions in accomplishing your objectives of Regulatory Compliance. Our C. E. O. has proven track record with more than a decade of balanced Industry Business. A Team of Professionals and Experts working with us. We Provide Quality Service on time.
Our organization serves according to country specific regulative services for registration of Drug product, API’s, Medical Device, Cosmetics, Dietary Supplements, seasoner medication, Veterinary product, Excipients and first Packaging Materials.
Our Goal is to be one of the landmark in the field of regulatory services all over the world. Quality add time is that the core of our business that results in your success. Hence, we have a tendency to believe developing sustained mutual useful relationship tailored to satisfy client’s needs and add price to their organization by minimizing each Time and cash spent.
CEO & Managing Director
Pharmaceutical Dossier is a collection of documents which provide detailed information about drugs to get licensed in Pharma.
Drug registration guidelines provide guidance to applicants who may wish to market their pharmaceutical products in the market.
All Technical Documents from Hostrin Life Sciences for Filing of a Marketing Authorization Dossier Towards Fast Track Approval
We are pharmaceutical regulatory techno commercial consultancy services has an outstanding performance in the field of pharmaceutical quality management, regulatory compliance and in particular of its Skills and Expertise in preparation and Compilation of Drug Master Files for API’s and Dossiers for Pharmaceutical formulations as per requirements of regulatory Authorities.
Our clients range from the major pharmaceutical companies to small start-up ventures and span all the continents of the globe, so no matter how large or small you are, you can be assured of our support