DMF (CTD format) Preparation
Business / Marketing
Hostrin life sciences is one of the well-reputed and prominent Regulatory Consulting Organization for the pharmaceutical and life sciences industry.
We are capable to provide documentation support for Tech pack and DMF’s for API’s and CTD’s, ACTD’s ,eCTD’s, ANDA’s for Formulations. We do support Tech Transfer for 3 plant validation batches along with documentation in customer site such as API’s , Formulations ( solid dossiers, capsule, injectables, spray, cream etc), Biotechnology, Bio similar products and Transdermal patches.
- Global pharmaceutical dossier registration services.
- Techno commercial services for API’s, Formulations, Bio technology, Bio similar s and Transdermal patches.
- Legal and technical solutions for all regulatory services.
- A new era of pharmaceutical innovation technical services.
- Clinical trail and non clinical trail support.
- Stability data support.
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.
- FDA accepted reference information.
- Compiling documentation and presentation in regulatory dossier services.
- Troubleshoots and fine tunes for your pharmaceutical technical needs.
- Suitable marketing collaboration support in regulatory and semi regulatory regions.
- We do support IPR services.
- Trade for fine chemicals, intermediates, API’s, impurities and formulations etc.,
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 associate .
As 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 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 & Experts working with us. We Provide Quality Service on time.
Pharmaceutical Dossier Management
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.
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Pharmaceutical Regulatory Solutions
Hostrin Life Sciences is a Pharmaceutical Regulatory Techno Commercial consultancy services. It is one stop Global Regulatory Solution provider to assist clients in seamless entry into Global regions by getting their products registered.
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Mode of Dossier Registration
We assist our clients for the registration of dossiers such as Non-ACTD, CTD, ACTD and eCTD in the MOH to their respective countries and DMF solutions for Pharma Export Registrations.
Regulatory Compliance
We do Dossier Preparation, Dossier Review and Registration of Dossier services in accordance with Dossier Compilation for both Regulatory and Semi Regulatory Regions.
Legal Documents Assistance
We provide assistance for Reviewing of Legal & Administrative Documents for infringing and non infringing routes, IP rights, brand, generic for the submission of International Dossier registration throughout the world.
DRUG REGULATORY WRITING
Regulatory medical writing has become more complex with the introduction of new requirements to secure drug approval. 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.
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DRUG MASTER FILES
Drug Master File (DMF) is a master document containing complete information on API. The DMF contains confidential information on drug product’s chemistry, manufacturing, raw materials, stability, purity, impurity profile, and packaging. Our service covers Type II DMF's for drug substances (API's) and Type IV DMF's for excipients (inactive ingredients).
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MARKET SUPPORT
We are doing consultancy for the market support by trading intermediates, API's (both Human and Veterinary) from grams, kg level and tonnage level also impurities from milligrams to grams level. We assist marketing support for formulations with different dosages, Bio technology, Bio Similars and Transdermal patches.
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