The pharmaceutical industry (or medicine industry) is the commercial industry that discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as different types of medicine and medications. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.
We offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. With our knowledge of the Indian regulatory scenario and its intricacies, we can help you achieve your goal without any hindrances. Our experienced team is well aware of all the formal and informal processes to be fulfilled on the path to complete approval and launch in the Indian market. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.
Entering into the vast realm of pharmaceutical products in international markets of EU, USA and other emerging ones like African subcontinent, requiresa comprehensive understanding of complicated regulatory requirements. At pharmxl, we ease the process of seeking swift approval for your products by defining country specific regulatory strategies right at the nascent stage of product development, eliminating potential roadblocks and ironing out any kinks en-route to a successful product launch.
The ACPL team puts together a time tested regulatory strategy, customized to your specific requirement that identifies and mitigates potential challenges in order to obtain approval for EU, USA and Emerging Markets. The team defines Clinical (CT/BA-BE, Published information, RLD/Comparator suggestion), Non-clinical (pre-clinical/Tox data) and Technical requirements (API and Drug Product specification & advise, Stability data, evaluation and proposed shelf life,) and helps in developing a quality product dossier. Furthermore, a country specific product strategy is developed. All these efforts are with one sole intent, 100% client satisfaction.Read More
DMF (CTD format) Preparation, Review and Submission Dossier Writing and Review Dossier Registration: Submission to various regulatory agencies worldwide Handling of query ResponsesRead More
ACPL provides post-approval services which include carrying out product re-registration is well ahead of time. Renewal of Site GNP is also carried out according to schedule. Services also include renewal of BE center GCP certification and submission of Annual Product Review Submission to the concerned health authority. The complete life cycle of the product is planned and executed by ACPL.Read More
DMF, GENERICS, IND/CTA/NDA, Pre-IND meetings / Scientific Advice meetings, Pre-NDA meetings
PharmXL provides exceptional value to the clients by rendering top-quality; cost-effective, customized, innovative, and timely drug regulatory services. We take responsibility and accountability for project performance, and strive to create a solution-based relationship. We are identified as one of the reliable providers of Drug Regulatory related Services. ACPL currently has clients in the United Kingdom, Republic of china and the United States of America and has provided technical guidance to them. Clients' projects have ranged from import to registration to new chemical entity registration to clinical phase. Various qualified personnel are appointed in to provide maximum benefit to the clients for availing and Drug Regulatory Services. We also provide regulatory consulting services to drug, medical device, biotech, and other medical companies to help them expand and retain their presence in the Indian markets.Read More...