Relationships with our clients are built on trust, transparency and reliability.
If we think of a better way of doing things – we’ll let our clients know and if we don’t know how to do something, we’ll find someone who can.
We know what our clients deserve and expect. We go the extra mile to achieve results and fit in with our client’s time frame and budget.
We keep up-to-date on changes in legislation, guidance and technology; our clients get the best advice in the most expedient manner.
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.
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.
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.
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.
We do Dossier Preparation, Dossier Review and Registration of Dossier services in accordance with Dossier Compilation for both Regulatory and Semi Regulatory Regions.
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.