CHINESE
Our Services
What We Do
Regulatory Services
- Regulatory due diligence and strategy
- Gap analysis
- MAA dossier – review and compilation of modules 1 to 5
- eCTD/NEES publication services
- Product information preparation – SPC, PIL and labelling
- Readability Testing and Bridging report
- Translation of product information text (and harmonisation for generics)
- Local regulatory support (e.g., local representative, preparation of locally required documentation)
- Services of EU QPPV and country specific local QPPV
- Deficiencies management
- Compilation of Major and Minor variation
- MA duplication procedure
- Regulatory services for specific countries e.g. LATAM, CIS + ex members, ASEAN, South Africa, ANZ, Botswana, Switzerland, etc.
Pharmacovigilance
- Signal detection – adverse reaction
- Drafting and submission management of PSUR, PBRER, PADER, Clinical Overview and DSURs: Comprehensive Pharmacovigilance Service packages for ROW region
- Establishment of PSMF and drafting of Risk management plan
- Literature search -Global/local literature search and review for reports of adverse events for all types of products, using standard terms
- Monitoring of literature for aggregated reports and safety information
- Scientific and medical writing: Drafting of Clinical/Non-clinical report or overview, narrative, IMPD with all regulatory compliance of EMA/any country.
Toxicology
- Preparation of Toxicology reports
- Calculation of PDE and NOAEL
- Cleaning Validation and MACO calculation
Impurity
- High quality analytical impurities and working standards
- Providing complete set of data HNMR, 13CNMR, Mass, HPLC, IR, TGA, COA along with products.
- Provide technical and analytical support to clients.
- Customize synthesis of product on request.
Pharmaceutical Translation
In the recent times, medical and pharmaceutical companies have started poaching markets across borders. Pharmaceutical companies have started manufacturing and marketing their products in multiple countries. However, before the companies can do so, there is a lot of documentation and formalities that must be completed. This documentation must be translated into the primary language of the country in which the company wants to manufacture or market their products. Hence, with the rise in cross border manufacturing units and marketing strategies, there is a steep rise in the requirement for pharmaceutical translation.
Interpretation Services
Whenever an individual wants to deal with people from other countries or cultures, he has two options – either learn their language and culture, or seek interpretation services. If one does not intend to live in a foreign country for a long time, then hiring an interpreter is usually the best option. Hiring an interpreter ensures that the individual can communicate with people in a foreign language efficiently.
Trademark
- Trademark Country Specific Search
- Trademark Filing- India, UK, USA
- Trademark Filing- Madrid Protocol
- Trademark Prosecution
- Trademark Opposition
- Trademark Infringement
- Trademark Litigation
Patents
- Patent Prior Art Search
- FTO Report
- Infringement Analysis Report
- Patent Drafting and filing in India, USA
- PCT Application Filing
- PCT National Phase Application Prosecution
- Post Grant and Pre Grant Oppositions
- Patent Infringement Suits
- Patent Litigation
Copyright
- Copyright Filing in India and USA
- Copyright TM-C certificate prosecution
- Copyright Opposition
- Copyright Infringement Strategy
- Legal Notice and Seizures
- Copyright Litigation
Complete Services related to IPR
- Consultation on IPR portfolio, branding from inception to execution and protection
- Consultation on IPR and its importance to your team with customized Content based Webinars and Workshops4
- Due Diligence of IPR Portfolio
- Analysis of IPR portfolio along with Infringement Analysis