DLV Biocare Pvt. Ltd.

Rohini, Delhi

Range :

• DLV-25AS-9mm
• DLV-25A-1 mm
• DLV-25A-2mm
• DLV-25A-3mm
• DLV-25A-4mm

Rnage :

• DLV-1 5AS-9mm
• DLV-1 5A-1 mm
• DLV-1 5A-2mm
• DLV-1 5A-3mm
• DLV-1 5A-4mm

Range :

• DLV-SS-9mm
• DLV-S-1mm
• DLV-S-2mm
• DLV-S-3mm
• DLV-S-4mm

Lati Consulting Services is operating as a reliable service provider and engaged in rendering the best in class solutions for Cosmetic Regulatory Services, Medical Device Regulatory Services, Drug Regulatory Services, Authorized Agent Services and Regulatory Submission Services. Whether you are a startup or a large multinational company, you can benefit from the experience and expertise of LCS to meet your objectives in a highly cost effective way. With our expertise in this arena, we provide complete assistance to help medical device, pharmaceutical, biotechnology and Cosmetics companies get their products to market quickly. LCS has provided support for more than 50 New Medical devices, 100 New Drug Application (NDA), Biologic License Application (BLA) and Abbreviated New Drug Application (ANDA) approvals and has provided drugdevice development services for new drugs devices in all major therapeutic areas. We provide resourceful methodical and regulatory consulting services to help ensure the continued success of your product post-approval.

In India, the latest Cosmetics Import & Marketing regulatory mandate, enforced from 1st April 2013, requires registration of the manufacturing sites and the products with the Indian licensing authority - the CDSCO. This activity is an essential requirement to ensure that Cosmetics Manufacturers based outside of India, can Import and Market their products in India.In brief, the cosmetics manufacturer needs to apply for the products' registration through their registered office in India, or their Subsidiary or through an Importer or a India based Authorised Agent. The actual application for product registration is submitted to the CDSCO, using "Form 42", the required essential documents and in the specified submission format. On successful review of the submitted dossier, the CDSCO will issue a "licence" in the form of a "Registration Certificate (RC)".This issued Registration Certificate, is both manufacturing site and product list specific. The manufacturer, through his subsidiary or importer or a India based Authorised agent can import the list of products specified in the RC only from the manufacturing so specified in the RC. In other words this RC is the equivalent of an Import License or Market Authorisation.LCS provides both Market Product Authorisation Services as well as Authorised Agent Services. An end-to-end service offering which will help you import and sell your product in India, so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities. Product registration services include the following : Regulatory Strategy Consulting and LiaisonComplete Product Life Cycle ManagementCompilation of India specific submission dossiersSubmission management leading to approvalsIndia Specific Labelling and Instructions for Use leafletsPost marketing services including Complaint handling, Query management & Submission activitiesAll statutory Marketing Authorization holder's requirements

LCSs consultants include former FDA officials and regulatory experts with industry experience. Our regulatory experts work with your company to provide a strategic analysis of your project to develop a realistic and well thought out plan with your goals in mind. Our strategic analysis includes a gap analysis based on the most current regulations requirements.Our highly experienced regulatory consultants bring a wealth of knowledge of the most up-to-date regulations, directives, laws, policies, and guidelines. It is our job to sort through the details, interpret guidelines, and recommend the right course of action for your organization.Many small and startup companies often cannot afford having their own regulatory departments. LCS is positioned to act as your Regulatory department on an as needed basis with significant cost savings. In serving your needs we provide value to your organization to avoid costly and sometimes irreversible mistakes. Our regulatory consulting includes but is not limited to : Regulatory strategic planning from design to market (e.g., Fast Track, orphan drug, drug vs. cosmetic) Product Classification Review (Devices, Drugs, Combination products) FDA meeting management for key Milestone meetings with Regulatory Agencies Medical devices regulatory support for Product Registration Labeling & advertising review Risk Management Plans India Agent status for non-India Companies

India authorized representativein order to legally register, import and market, sell your medical products in india you need to be compliant to indian regulations and legislation. When a company does not have a registered and physical office with statutory personnel and required licenses in india, a legal india authorized representative agent with the above needs is to be formally appointed. This authorized representative will also be held responsible for pre-certification and post-market surveillance inquiries.lcs will represent your organization as your official indian authorized representative agent in accordance with india applicable regulatory legislation: the drugs and cosmetics act and rules.only one indian authorized representative office is needed for the whole country. Lcs will represent you legally in india without any commercial conflict of interest activities like product distribution, product marketing, product sales etc. retain full control over product distributionmany product distributors are happy to take on the role of an official indian authorized representative. This relationship would curtail the manufacturers ability to work with multiple distributors in india or change distributors due to performance challenges.since the appointed india representative is identified on the cdsco product registration documents and tied to the manufacturing site and product approval for its three year duration, if a distributor is appointed as the authorized representative, this relationship cannot be changed at least for a period of three years. Also, this can become problematic because if you decide to switch distributors you will need to start the registration process all over again.

The LCS regulatory affairs strategy is characterized by both efficient preparation and execution of development plans and interfacing with regulatory agencies. Our scientific and regulatory experts consider FDA guidance documents, requirements of the International Conference on Harmonization and other regulatory agencies, and currently marketed products to ensure attention to detail in the preparation and submission of regulatory documents. This strategy has successfully helped clients reduce development time and accelerate the movement of new products to proof-of-concept and global commercialization for medical devices, pharmaceuticals and biologics. The regulatory affairs experts at LCS have experience in all major therapeutic areas and have had successful interactions with all regulatory divisions within the regulatory agencies. Our team of industry-trained scientific and regulatory consultants will support your product throughout the entire development continuum, from concept and strategic development, to proof-of-concept and market approval, to post-approval maintenance. We provide regulatory affairs solutions for full product lifecycle management. Our regulatory expertise also includes solutions to help clients navigate the complex requirements for expedited programs.

Clients prefer us for our sincerity in providing Regulatory Submission Services, our professional behavior and timeliness. Our services are appreciated for their excellence as well as we completion within the pre-defined time. Our experienced personnel are there to guide the clients and help them in meeting their exact requirements. As a trusted name, we work in complete coordination with the clients. Moreover, our services are available at reasonable charges. Our regulatory submission services include :Drug submissions : IND, NDA, CTD, ANDAs etc.Medical Device submissions : Registration Certificate, Import License, Test License, Clinical Trail application , shelf Life Approval, Model Addition to the existing registered Products, Notification and clarification for major and minor changes, adding new indication to already registered products, endorsement app to the Registration CertificateInvestigators Brochures and Briefing DocumentsClinical Trial Documentation : Protocols, Informed Consent Forms, and ICH-compliant Clinical Study ReportsCosmetics Submission : Registration Certificate, Notification and clarification for major and minor changes, endorsement app to the Registration Certificate.

Details : Our Consultants team provides accurate documentation compliant with guidelines and regulations. Our highly qualified staff will work closely with your team to produce precise documentation for a wide variety of drug therapeutic areas and medical device categories. Our staff have scientific degrees and have experiences in many therapeutic areas. Our Consultants team averages over 10 years of experience. And no matter what template, writing style or electronic document management system you follow, they will write and finalize documents within your specifications. Our regulatory submission services include :Drug submissions: IND, NDA, CTD, ANDAs etc.Medical Device submissions: Registration Certificate, Import License, Test License, Clinical Trail application , shelf Life Approval, Model Addition to the existing registered Products, Notification and clarification for major and minor changes, adding new indication to already registered products, endorsement app to the Registration CertificateInvestigators Brochures and Briefing DocumentsClinical Trial Documentation: Protocols, Informed Consent Forms, and ICH-compliant Clinical Study ReportsCosmetics Submission: Registration Certificate, Notification and clarification for major and minor changes, endorsement app to the Registration Certificate