Regulatory Affairs

Regulatory Affairs

Health Authorities have meticulously devised complex rules and regulations for the development of pharmaceutical products and regulating their commercialization globally. Regulatory Affairs team liaises between Health Authorities and Pharmaceutical Organizations to ensure all obligatory requirements are successfully accomplished on time and compliance with regulations throughout the life cycle of the drug. Pharmaceutical Organizations are constantly challenged by the daunting and mammoth effort required for scrutinizing, deciphering, and tracking key regulations and steps related to the stringent drug approval process.

We are a global leader in the Regulatory space and excel in bridging Global Health Authorities and Pharmaceutical Organizations. We are well equipped to deliver strategic and multidisciplinary Regulatory Affairs services through drug development, registration, commercialization, and managing regulatory compliance. We enable our customers to successfully launch their products globally despite complex and demanding regulatory requirements with our domain expertise and meticulous tracking.

Our expert team comprises of specialists who can navigate products through the complete regulatory approval process, along with devising specific strategies for agency interface, managing regulatory strategy, GAP analysis, product classification, authoring dossiers, the development and update of labels and common technical documents, submission preparation, publishing, regulatory intelligence, and Quality Assurance for various categories of products.

We understand the changing needs of a Marketing Authorization Holder and act as an extension of its team to ensure post-authorization requirements regarding quality and safety are achieved. Our regulatory operations experts are specifically skilled to optimize renewals, variations, and other lifecycle management activities. Our multi-disciplinary expert team can also customize specific services related to Clinical Trial registration and safety reporting to fit client requirements. The strong scientific background of our experts coupled with up-to-date regulatory expertise enable our clientele to recognize efficient regulatory strategies, monitor the approval process and succeed with marketing authorization.

Preparation and Submission of Regulatory Dossiers for Clinical Trial Approvals and Marketing Authorizations

Marketing Authorization / license / approval (investigational new drug approval and new drug approval) is a mandatory requirement for any product before commercialization and used in Humans. The content and format of various regulatory agencies are specific to territories makes compiling a dossier very pain staking. We can customize our services by providing both complete and partial dossier preparation with high levels of quality and compliance. We guarantee on time submissions to enable our Sponsor achieve their Approval / Authorization timelines. We are up to date with relevant regulatory requirements and efficient in managing physical dossier submission required by specific territories. Our experts are proficient in electronic dossiers management and empower our Sponsors to achieve compliance to rules and regulations specified by relevant Health Authorities.

Seamless product commercialization, prompt responses on approvals and submissions can be effortlessly achieved by timely and effective communication with Regulators. Pre-submission interactions and meetings with Health Authorities are vital occasions for understanding the Regulator’s requirements in detail and clarify the applicant’s strategy for specific submissions. We can act as an extension of our Sponsor for various types of meetings and interactions thereby navigating the product throughout the development cycle towards successful Regulatory approval. We are experts in preparing meeting materials, managing queries and support our Sponsors with guidance and expert advice on deficiencies noted during the life cycle of the product submission and approval.
Drug master file is one of the most integral part of any registration application or Marketing Authorization and contains chemical information, manufacturing aspects as well as information on the control of the active pharmaceutical ingredient. Our robust interdisciplinary experts help review Sponsor’s technical documents compiled in any format for its submission to regulatory authorities across the globe. We deploy a methodical and pragmatic review process that enable our Sponsor to present Regulatory Agencies with appropriate information to successfully conclude on whether the benefits outweigh the risks and establish the safety and efficacy of the investigational product for seamless navigation of product through the approval process.
The protocols undergo stringent review process and are required to be presented to expert committees appoint by regulators in an attempt to reinforce the scientific review in approval of drugs and devices. Along with the application, the safety and efficacy data for the medicinal product should be presented by the Sponsors to the committee for decision on approval of the product. We understand regulators approach towards scientific evaluation during approval process and can help us Sponsors by providing appropriate assist in preparing the presentations and advise on its delivery along with technical reviews and query responses for combinations products, various formulation and mixed dosage forms.
Clinical Trial Registries are usually collaborative libraries that publicly present information regarding clinical trials in an attempt to link patients to research. Advance entry of clinical trials in national agencies is a regulatory requirement that requires tedious preparation where our experts can efficiently support both our Sponsors and Investigators with our robust system for both interventional and observations studies. We can partner with our Sponsor and take complete responsibility of registering, periodic review and update with high standards of quality.

Most Health Authorities have mandated submissions of safety data to be made electronic along with other essential regulatory submission and approval documents. Our experts are well versed with leading publishing tools and safety submission requirements of global regulators. We strive to be compliant to every Health Authority requirement and employ stringent quality check mechanism to ensure the reporting is complete and meet the electronic reporting requirements of each Health Authorities. We support safety operation of our Sponsor with extensive tracking mechanism and notifications to ensure reports like Periodic Safety Update Report, Periodic Benefit Risk Evaluation Report, Periodic Adverse Drug Experience Reaction, Annual Summary Report are completed and submitted to Regulators within defined timelines.