- DRUG REGULATORY SERVICES
We help manufacturers overcome regulatory barriers by preparing strong regulatory strategies and dossiers for filing applications for approval of their drugs. Our professionals represent our clients at SEC meetings to get approvals and permissions. Our vigorous follow-up for services like clinical trial management, medical writing, etc. enables our clients to get approvals/permissions without any hassle.
- FOOD AND NUTRACEUTICALS
Over the years, we have acquired an in-depth understanding of the rules laid down by FSSAI through careful monitoring of the changing laws and constant professional liaison with other regulatory bodies. Our committed team is constantly prepared for challenges and changes in order to help you achieve your goal without any hassles. All matters related to FSSAI compliance and import assistance is handled by us with strategic planning and technical acumen.
Our Medical Services consist of assisting you in conducting getting clinical trials, Pharmacovigilance, and Medical writings. These services are provided by our sister concern PharmXL.
For further details please follow the below links:
Clinical Trials: http://pharmxl.com/Web/Clinical_Trial_Service
Medical Writing: http://pharmxl.com/Web/Medical_Writing_Service
- MEDICAL SERVICES
All Medical affair (Clinical trials, Pharmacovigilance and Medical writing) services provided by our sister concern company PharmXL.
For further details please follow the below links........
Clinical Trials : http://pharmxl.com/Web/Clinical_Trial_Service
Pharmacovigilance : http://pharmxl.com/Web/Pharmacovigilance_Service
Medical Writing : http://pharmxl.com/Web/Medical_Writing_Service
- REGISTRATION OF COSMETIC PRODUCTS
Every cosmetic product sold in India has to be registered. This process requires meticulous planning and review of the ingredients and the product label. Any company intending to import and market cosmetic products has to go through this process. The cosmetic application should clearly define the products in their respective categories. With years of experience behind us in assisting several product registrations and certifications, we are the regulatory partner you need to guide you through the entire process of completing the registrations without any glitches.
- MEDICAL DEVICES SERVICES
Presently, regulations for medical devices in India are still evolving. Only a few selected products need a medical device permission to be sold
In the past few years, there have been three major announcements outlining the medical device products that need to be registered. Till 2005, only medical devices such as disposable hypodermic syringes, condoms, tubal rings, metered-dose inhalers (MDIs), etc., had to be registered in India.
- DIAGNOSTIC KITS
We offer end-to-end regulatory support for Diagnostic Kits starting from applying and obtaining manufacturing licenses from CLAA and SLA for notified and non-notified medical devices, to securing registration and import licenses. Applications for acquiring test licenses and import licenses for new diagnostic kits are handled by our team of experts who have a thorough knowledge of the subject. We assist our clients in providing responses to clarifications asked by CDSCO or any govt. agency. We analyse the parameters required for Performance Evaluation from NIB by preparing a strong document in support of the application which in turn practically reduces the chances of any sort of rejection.
- BIOLOGICAL REGULATORY SERVICES
Biologicals are the medicinal, therapeutic/ diagnostic/ preventive preparations that are prepared from living organisms and their products for human use. They include serums, vaccines, antigens, antitoxins, etc. Biotechnology is used as a unique approach in manufacturing such medicinal agents. We provide all round support in the manufacturing and import of such products, vaccines, etc. in India. We assist our clients in meticulous verification of the dossier and other documents to be filed with the govt. so that the application is approved in one go.
- PESTICIDES & INSECTICIDES
Meeting the agricultural demands of the ever increasing Indian population needs continued innovation.Agriculture is the backbone of India and its economy. A good agricultural yield depends on various factors including seeds, fertilizers and pesticides. Pesticides are chemicals used to destroy, suppress or repel any unwanted plants or animals, particularly those hindering the optimum yield of the end product. Pesticides can be divided into several subcategories including fungicides, bactericides, rodenticides, herbicides and insecticides.
- CONTRACT RESEARCH ORGANIZATION – CRO
A contract research organization (CRO) is an organization supporting the pharmaceutical, biotechnology, and medical devices industries by providing professional services by outsourcing research on a contractual basis. CRO is a highly skilled organization supporting research foundations, institutions, and universities as well as governmental organizations including the National Institutes of Health (NIH) and European Medicines Agency (EMA). The services provided by a CRO include the development of biopharmaceuticals and biological assays, commercialization of products, pre-clinical research, clinical research, management of clinical trials, and pharmacovigilance. However, searching a reliable, certified, and skillful CRO needs extensive survey and time. ACPL provides a systematic, scientific and synergistic approach to handle all regulatory affairs. We have a set of reliable industry experts who assist our clients to identifying the perfect CRO for their needs.
- NARCOTICS REGULATORY AFFAIRS
The word narcotic comes from Greek word “narkos” meaning sleep. Specifically, narcotics includedrugs like heroin, morphine, coca leafs, cannabis (hemp), opium poppy straw and other related drugs. Any narcotic drugs and psychotropic substances can be manufactured, imported into/ exported out of India subject to Rule 53 and Rule 53-A of Narcotic Drugs and psychotropic substances Act, 1985 (NDPS Act, 1985). A specific permission from Central Bureau of Narcotic (CBN), Gwalior, Madhya Pradesh, India. Extremely stringent guidelines have been laid down by the Indian government to ensure that their sale and manufacture is regulated.
Certain products that are exported require certain documents along with the shipment as per the regulations of the importing country. Some of these documents like Power of Attorney, GMP certificate, COPP, COO, or any other commercial document related to pharma are required to be attested/notarized/ legalized from the embassy (Ministry of External Affairs) of the importing country in exporting country. We have a specialized team which focuses on all the legal documentations, notarizations, attestations, apostilization, and legalizations.
As we are based in New Delhi, we have close proximity to many embassies and hence, can get the documents legalized swiftly from them. Some of these are Nigeria, Columbia, Myanmar, Dominican Republic, Thailand, Philippines, Jordan, UAE, Singapore, Algeria, Chile, Ethiopia, Taiwan, Vietnam, Russia, Peru, Paraguay, Guatemala, Trinidad & Tobago, Mexico, Panama, Ukraine, Taiwan, Bangladesh, Iraq, Turkey, etc.
- BIOLOGICAL SAMPLE – ICMR
Perhaps the most important leg of clinical research are biological products and their procurement. Often product launches are delayed due to red tape and completing the paperwork for meeting government guidelines. ACPL specializes in cutting through this chaos and setting your clinical research on a smooth sailing journey right from the first step. We understand the importance of timelines and function as well-oiled machinery that can deliver services on the expected date and time and that too glitch-free.
The Indian Council of Medical Research (ICMR) has set stringent guidelines and criteria to be met for the approval of various types of biological material samples. It regulates by way of periodical revisions in addition to approvals from CDSCO. Approvals are also required by other offices and agencies at the district, zonal state, and national level
By applying technology, creativity, and focused multi-disciplinary approach, internally as well as externally, we improvise processes and accelerate approvals. Our service aims at leveraging models that are cost-effective in the long run and help in the growth of new products along with sustenance of established products.
- LEGAL METROLOGY
The Legal Metrology wing of the Department of Consumer Affairs came into being in 2009 and deals with the monitoring and regulation of manufacturing, import, and business of weighing and measuring instruments and devices including import and sale of pre-packaged goods into India.
At ACPL, we assist manufacturers and importers of weighing and measuring instruments and devices including importers of pre-packaged goods to obtain appropriate licenses and approvals for marketing and selling their products in India. We assist the client by preparing on their behalf all documents to be submitted to the department and thorough follow to obtain the requisite licenses/certificates in the shortest possible time.
- DISPOSABLE AND PROTECTIVE CLOTHING
We can supply any quantity of Non-woven Full Body Coverall Disposable Isolation Clothing Suit Protective Suits.
Its’s specifications are : Anti-synthetic blood penetrability grade 6, surface moisture resistance grade 4, high barrier material filtration efficiency 99.99%, water-resistance of 20 kpa, moisture permeability of 6657g.
The product is synthesized from high-quality non-woven fabric and PE breathable composite film; lightweight, soft, non-toxic, non-irritating, antibacterial, anti-chemical agents, antibacterial, and good physical properties. It is suitable for providing medical personnel with barrier and protective effects when they come into contact with blood, body fluids, secretions, and particles in the air of potentially infectious patients.
Product Name: Isolation gown safety clothes
Sizes: S, M, L, XL, XXL