Dr. SSK Labs Pvt. Ltd. provides method development and validation services for a wide range of analytical technologies. Compliance with both GLP and cGMP regulations enables the company to support all stages of pharmaceutical development in accordance with client- protocols, internal SOPs and FDA and ICH guidelines. The Analytical Development lab is equipped with HPLCs with PDA/UV detector, GC-FID with head space sampler, GC-HS-MS, UPLC, UPLC-MS, Atomic-absorption Spectrophotometer, FTIR, UV-Vis Spectrophotometer, Total organic carbon analyzer and XRD. We offer comprehensive routine analytical services as well as ad hoc and highly specialized testing services using modern technologies. Analytical Research and Development involves pre-formulation, stability and degradation studies on APIs and other drugs. The Analytical Development team provides specific services to various Pharmaceutical Companies.
- Provide short and long term regulatory strategy for medical devices, IVDs, and combination products
- Serve as expert witnesses for litigation matters related to medical device regulation and technologies
- Conduct due diligence assessments
Project Management: An organized and efficient project manager can be the difference maker in the execution of a successful project.
- Have a strong knowledge of FDA regulations, guidance and expectations based on direct experience,
- Interact with FDA project managers and reviewers on a daily basis as the primary point of contact for US Agent clients,
- Follow trends within Centers and Divisions with regard to current practices,
- Provide regulatory and product development guidance,
- Serve as a primary point of contact for project coordination,
- Coordinate writing, review, strategy discussions, publishing and application life cycle maintenance activities,
- Advise on optimal practices to create efficient, reviewer friendly applications,
- Provide regulatory and submission guidance,
- Accompany Sponsors to FDA meetings and participate in teleconferences.
Electronic Publishing & Submissions: The electronic publishing and submissions group provides clients with an array of tools and services that enhance collaboration, streamline the application drafting process, and reduce regulatory review times.
- Customizable, compliant document templates,
- Complete, reviewer-friendly submissions in a guidance-compliant eCTD structure,
- Reliable and secure transmission of documents to FDA via our Electronic Submissions Gateway (ESG),
- Maintenance of applications throughout the eCTD lifecycle, ensuring that reviewers have the latest information at their fingertips,
- Assistance in transitioning existing paper and NeeS (non-eCTD electronic submissions) applications to eCTD format.
Staff Augmentation: For many biotechnology companies, maintaining a full complement of product development experts, from nonclinical researchers to clinical trial experts, medical writers and regulatory professionals is not possible. However, lacking access to these experts hinders the progress product development.
- Employ a full roster of consultants in every area of pharmaceutical, biologic/biosimilar, medical device, and therapeutic product development,
- Offer our clients the opportunity to make our team yours, on-demand,
- Provide a team able to step in to augment your current team, providing you with the benefits of a world-class staff at a fraction of the cost,
- Work with firms of all sizes on projects of all magnitudes,
- Bring a unique insider perspective to each engagement, allowing you to maximize the value of every dollar spent while accelerating your development timeline.