- Drug Regulatory
Factory Premises & Product Registration for the purpose of Importation of Drugs, Medical Devices,Raw Material,Cosmetics
Form 10 or Import Permit
NOC for Import of Half finished or Raw materials.
Legalization of Export/Import documents
Neutral Code Licnece
Any other Organizational Clearances say Animal Husbandry, Diary Products Etc
Information Regarding any types of Queries under Drug Rules & Custom Rules2
- Food and Nutraceuticals
Over the years, we have forged an in-depth understanding of the rules laid down by the FSSAI through careful monitoring of the changing laws and constant professional liaison with apex regulatory bodies of India. Our committed team of experts is constantly prepared for challenges and changes in order to help you achieve your goal along with our license without any hassles. All matters related to FSSAI compliance and import assistance is handled by us at ACPL with strategic planning and technical acumen.
- Medical Affairs 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/pre_clinical_trial_service
Pharmacovigilance : http://pharmxl.com/Web/pharmacovigilance_service
Medical Writing : http://pharmxl.com/Web/medical_writing_service
The cosmetic registration process requires meticulous planning and review of the ingredients and labeling for registration in India. Any company intending to import and market cosmetic products has to go through this tedious process. The cosmetic application should clearly define the products in respective categories. With years of experience behind us in assisting several product registrations and certifications, we are the regulatory partner you need with you through the entire process in completing the registrations without any glitches.
- Medical Device
Presently, the regulations for medical devices in India are still evolving. Only a select few products need a medical device permission to be launched. In the past few years, there have been three major announcements outlining the medical device products that need to be registered.
Up to 2005, only medical devices such as disposable hypodermic syringes, condoms, tubal rings, metered dose inhalers (MDIs), etc., had to be registered in India.
- Diagnostic Kit
We offer end-to-end regulatory support for Diagnostic Kits in India starting from procuring the manufacturing licenses from CLAA and SLA for notified and non-notified medical devices, to securing registration and import licenses for imported Diagnostic Kits. Procedures for acquiring test licenses and import licenses for new diagnostic kits are also handled by our team of experts. We assist our clients in providing responses to clarifications asked from CDSCO. Our personnel with in-depth knowledge backs our clients in analyzing the parameters required for Performance Evaluation from NIB making a strong documentation support for the application which reduces chances of rejections at any stage practically nil.
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 biological products, vaccines, etc. in India, assisting our clients in detailed filing of dossier as required and do rigorous and careful verification so as to successfully file the application 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.
A contract research organization (CRO) is an organization supporting the pharmaceutical, biotechnology, and medical device industries by providing professional services by outsourcing research on a contractual basis. They are also highly skilled to support research foundations, institutions, and universities as well as the governmental organizations including National Institutes of Health (NIH) and European Medicines Agency (EMA). The services provided by a CRO include development of biopharmaceuticals and biological assays, commercialization of products, pre-clinical research, clinical research, management of clinical trials, and pharmacovigilance. To perform multitasking in a defined timeline, a CRO is a boon for all the pharmaceutical as well as research needs. However, searching a reliable, certified and skillful CRO needs extensive survey and time. There is no need to worry when ACPL is there to help! 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 collaborate 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.
Any product that is exported to a particular country requires certain documents along with the shipment or beforehand as per the requirements and regulations of the importing country. Some of these documents like power of attorney, GMP certificate, COPP, COO any other commercial documents related to pharma is asked to be attested/ notarized/ legalized from the embassy (Ministry of External Affairs) of the importing country in Exporting country. This attestation/ notarized is mandatory to be done which ensures or verifies that the documents are original and from the country of origin/exporting country. We have a specialized team who focuses on all the legal documentations, notarizations, attestations, apostillation and legalizations. We assure complete satisfaction to our clients.
As we are based in New Delhi, we have close proximity to the following Embassies and hence, can get the documents legalized swiftly from different embassies in the Ministry of External Affairs (MEA) in India like Nigeria, Columbia, Myanmar, Dominican Republic, Thailand, Philippines, Jordan, UAE, Singapore, Algeria, Chile, Ethiopia, Taiwan, Vietnam, Russia, Pakistan, 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 research and product launches are delayed due to red tape and paperwork over government guidelines at this very initial step. ACPL specializes in cutting through this chaos and setting your clinical research on a smooth sailing journey right from this step. We understand the importance of timelines and function as a well-oiled machinery that can deliver services on the expected date and time, glitch- free.
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 growth of new products along with sustenance of established products. We commit to periodic and smooth safety reporting to regulatory authorities and global Ethics Committees.
The Indian Council of Medical Research (ICMR) has set stringent guidelines and certificates to be obtained for 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
- Legal Metrology