Experts in regulations related to Ayurveda (AYUSH), Food (FSSAI), Drug approvals & Clinical trials (Global as well as Indian), Product labelling compliance, import and export requirements, and Drug pricing policies etc.
Specialists on Ayurveda Products for Product launch – end to end consultancy including Ingredient’s finalization, Product format, Claim and Claim substantiation requirements, DMRA (Drug and Magic Remedies Act) compliance, ASCI (The Advertising Standards Council of India) representation, Quality Aspects including suggestions on Standardized Herbal Extracts, Bio-marker Based Quality Control Requirement, Labeling Requirements etc.
We also help companies develop formulations for their Ayurvedic products that meet regulatory requirements and are effective in treating the targeted condition. We provide guidance on the selection of active ingredients, excipients, dosing, and the use of different delivery systems.
Consultation on Nutraceutical, and other Specialized Foods including Health supplements, Botanicals, FSDU (Food for Special Dietary Usage). FSMP (Food for special medicinal purposes) Labeling Requirement, Regulatory and Licensing Requirements, Labeling requirements, Advertisement requirements, Quality Control Requirements etc.
Dossier Compilation for New Drug Approval, SEC Presentations, submission in SUGAM portal etc.; covering collection, collation and compilation of required literature on safety, efficacy, quality (collectively in collaboration with Sponsor company) and transforming the information in desired format for submission in CDSCO (Central Drugs Standard Control Organization) required format. Technical, Scientific and Regulatory review of drug applications, documents required for submissions to ensure accuracy, completeness and compliance. In addition, post-approval regulatory compliance check, including adherence to labelling and advertising guidelines, adverse event reporting, and pharmacovigilance.
We offer expert guidance on conducting clinical trials in compliance with regulatory requirements for New Drugs, Ayurveda Drugs, including identify suitable CRO to ensure that the clinical studies are conducted ethically and scientifically taking care of patient confidentiality and safety. Scientific and regulatory review of all essential documents viz. Protocol, CRF, ICF, IB, IMPD etc.
We provide guidance on scientific aspects related to protocol design, CRF designing, data management, informed consent forms and monitoring and audit related compliance, taking care of the ethical and safety standards during the clinical trial management process. We help the companies to prepare regulatory submissions related to clinical trial applications to the concerned division at CSDSCO, and also provide support for post-trial activities like scientific publications etc.
Regulatory compliance is critical to the success of any pharmaceutical / AYUSH/ FSSAI product. We help companies navigate the regulatory landscape and ensure that product meets the necessary regulatory requirements.
Intellectual property protection is essential in the pharmaceutical industry, and pharma consultants can provide guidance on patent law, trademark law, and other intellectual property issues.