We have a proven competitive efficiency to manage your Regulatory Affairs
Regulatory Affairs (RA) is a profession within the healthcare industry namely, Pharmaceutical, Medical Device, Biologics, & Functional Food. Their main role is to comply with Safety & Efficacy of the products as per regulation laid down by the government. They advise companies on all regulatory aspects and laws pertaining to their business such as the promotion of the prescription drug. It is with specific meaning within the healthcare industries. Tech Tammina is established as a professional organization to reinforce and represent these regulatory industries and affairs. In the pharma industry, it is defined as the interface between the pharmaceutical company and the regulatory agencies across the world. The main goal of the regulatory affairs as the profession is to the protection of human health, ensuring safety, efficiency, and quality of drugs with the main accuracy of product information. It helps in analyzing the complicated information including trail data.
Tech Tammina offers effective Regulatory Affairs Service for all levels of pharmaceutical, biological and medical device product development industries. We adopt unique strategies to explore full regulatory affairs support services. We have a team of interdisciplinary and flexible resources who can provide responsive and extensive results to your needs. Tech Tammina ensures you to provide benefits to the expertise regulatory professionals. We take the responsibility by contributing to the public health and welfare. Our professional regulatory keeps on tracking the products by carrying out subsequent negotiations that are required to attain the status of products authorization. We are here to offer pragmatic, robust and well-supported functions from the beginning of the development of a product to till marketing the product to achieve success either commercially or scientifically.
Regulatory Compliance & Risk Management
We empower your organization by navigating the global regulatory requirements, enterprise risk management, and compliance factors. We tackle your organization brand by scrutinizing the extrapolative business model challenges or changes, stakeholder’s expectations, anti-fraud measures, financial reports, and financial advisory services. We provide the disciplinary ideas of GRC metrics that enhance your business that aspires to synchronize information of risk management and regulatory compliance in order to wield more efficiently that authorizes efficacious information, reports sharing, coordination and utilization of people, managing costs. All the various challenges are faced in the highly regulated industries like financial services, life sciences, healthcare that helps in determination of right compliance with roles and accountabilities between business functions and audit.
By following these regulatory compliance and Risk Management, the Organizations compliance can be easily improved which reduces the risk of the journey from the volume of values. To avoid risk, the effective approaches to the regulatory change management process involve the high level of engagement. Step by step methodologies is involved in every activity which is involved in the compliance process that directly helps to put a clear focus on the individuals. We offer seamlessly end-to-end process design or redesign with our proven staff of risk management and compliance professionals to make your organization dream come true.
Regulatory Affairs Outsourcing Services
- Post-approval maintenance
- Regulatory dossier compilation, publishing and dispatch
- Content creation and document services
- Investigational filings and maintenance
- eCTD Submission and lifecycle maintenance
- Market authorization filings
- Product labelling and artwork management
- Drug development support
Pharmacovigilance is also known as drug safety. Tech Tammina provides complete pharmacovigilance services for all drug dosage forms with wide range of product types. Tech Tammina provides services where Qualified Person Responsible for Pharmacovigilance (QPPVs) worldwide based on client requirement and operational team have hands-off experience to monitor the safety data for defined dosage forms. In order to reach people safety our team manage the client requirements in compliance and manage their commitments for drug safety as well as patient safety by monitoring the hierarchy of pharmacovigilance data in definable manner. Tech Tammina have flexibility working with small clients to global multinationals to provide 24/7 support.
Why Tech Tammina?
Tech Tammina provides a wide array of regulatory affairs services through our dedicated consulting teams. Our professional consultants help and enhance the services in globalizing your products through our regulatory affairs solutions. We assist you by providing the appropriate regulatory affairs services such as regulatory dossier compilation, eCTD publishing & submission. Our ultimate support is available 24/7. If you are looking for services which can run your regulatory needs in a well-organised way, Please, Drop your requirements in our contact us page.