OUR SERVICES

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 Narcotics (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.

Our services offer the best solutions to meet all kinds of challenges for Export and Import of Narcotics Drugs, Psychotropic Substance and Precursor Chemical, Methyl Ethyl Ketone, Formulations, Quota allocation, Online Psychotropic Substance submission, Import of Poppy seeds.

• Company registration with Central Bureau of Narcotics – Gwalior
• Obtain Manufacturing License / Renewal of Manufacturing License
• Product registration with Central Bureau of Narcotics
• Export / Import NoC from Central Bureau of Narcotics
• Online & Offline Return Filings to Central Bureau of Narcotics

We provide a full range of Food and Pharmaceutical Regulatory Affairs consulting services to the Pharmaceutical, Biotechnology and Healthcare Industries. Our expertise covers all stages of the product lifecycle and each service is delivered by a specialist in their field with the relevant knowledge and experience.

Our Services Include:

• Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format,ACTD Format& Country Specific Guidelines).
• Drug Master File (DMF) compilation for open and closed part.
• Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
• Expert reports on Quality , Pre-clinical and Clinical.
• Orphan Drug Application Preparation and Submission.
• Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
• Assistance in Response to queries for submission to the Regulatory Agencies.
• Total development of product from lab scale to pilot plant scale to actual production scale for Drug Substance and Drug product.
• Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.

Periodic Safety Update Report (PSUR) preparation.

• Provide analytical support in analytical method development / validation, Routine analyses of products by HPLC/GC/MS etc.
• Complete stability programme management service is provided as per ICH guidelines / special requirements in a cGMP and GLP compliant environment.
• Monitoring and liaisoning with the CRO’s for Clinical and BE Studies.
• Compilation of dossier as per latest country specific guidelines.

Scientific Services:

Achieve your quality and compliance goal. Our experts will guide on your individual compliance requirements to develop an effective risk management strategy.

• Prepare & review GMP and technical documents
• Product complaints
• GMP readiness audit & licensing assistance
• Product quality review & recommendation on various quality issues
• Recall management, communication and support
• Wholesaling/Distribution assistance
• Quality Management Systems (QMS) solution
• Certificate of Pharmaceutical Product (COPP) & Free sales certificate
• Depending on needs of our valued clients, we are providing the range of contract manufacturing services

Medical Services:

• Pharmacovigilance support
• Medical information support: promotional material review, development & review of educational materials
• PSUR and RMP support
• Pharmacovigilance inspection-audit readiness reports

Indu Regulatory Services (IRS) provides a concise and streamlined food supplement regulatory service; to help companies successfully market their products without getting held back interpreting complex legislation. Food supplements also known as nutritional supplements, Nutraceuticals or dietary supplements covers many aspects of European and national law such as: Food Safety Regulations, Food Supplement laws, Enzyme, Food additives &Flavouring rules, Nutrition and Health claims, Novel Foods legislation and Import guidelines.

From single in-depth product evaluations, simplified regulatory guidelines to streamlined analysis of whole product lines, we tailor each project to suit the client’s needs

PRODUCT EVALUATIONS:

Indu Regulatory Services (IRS) advise whether your products are classed as a food supplement and provide advice on adjustments in order to comply. We inform companies of the exact status of ‘grey area’ ingredients such as amino acids, botanicals, essential nutrients and enzymes. We also advise whether the product in fact a Medicine, a Traditional Herbal Product or a Medical Device.

NUTRITION AND HEALTH CLAIMS:

We analyse nutrition and health claims and the Scientific Opinions of the Food Standards Agency to advise how to legally market products and build your strategy.

Our services also include the following:

• Product Approval (Health Supplement & Proprietary Food)
• Health claim dossier
• Central License, State License & State Registration

LABELLING AND COPY REVIEWS:

Indu Regulatory Services (IRS) assess food supplement product labels and packaging copy to provide simple edited instruction documents for compliance with food supplement labelling legislation.

ADVERTISING AND MARKETING REVIEWS:

Indu Regulatory Services (IRS) appraises natural product websites and advertising literature to make sure it complies with Advertising Standards Authority.

NOVEL FOOD APPLICATIONS:

A novel food is defined as a food that does not have a significant history of consumption. Such foods require a pre-market safety assessment in the form of a Novel Food application or a simplified procedure for ‘substantial equivalence’ foods. Indu Regulatory Services compiles novel food applications dossiers; covering history of use, intended purpose, nutritional value, composition, toxicological and nutritional data.

We can assist with project management and registration of such products and have valuable experience in this area. We can work with you to guide you through the necessary requirements under the Directive that you will have to comply with. We can either prepare for you or help you to prepare a submission for a traditional herbal medicinal product, including vital pre-submission discussions with the Health Authorities.

Our services include the following:

Preparation and review of Traditional Herbal Registration Dossiers

• Preparation of Patient information leaflet (PIL), writing, proof reading, and user testing: for compliance with labelling laws.
• Registration of traditional herbal medicines
• Product Rationale on scientific basis

Indu Regulatory Services (IRS) provides regulatory compliance consultancy to cosmetic suppliers, distributors and manufacturers. We provide client tailored guidelines on all aspects of cosmetic regulations.

The cosmetics market is highly competitive and ever growing, particularly organic and natural source products. Significant investment is required to market cosmetic products across many mediums, so it is important to get cosmetic compliance right.

• Conducting audits of cosmetic manufacturers to assure compliance with GMP guidelines
• Reviewing cosmetic labelling for compliance with FDA requirements.
• Evaluating the safety of cosmetic ingredients.
• Preparing colour additive petitions for submission to Regulatory Authority for approval.
• Designing clinical studies to document safety of ingredients, and to substantiate label claims.

We offer CRAMS (Contract Research and Manufacturing Services-Contract Manufacturing) of all Dosage forms

Depending on needs of our valued clients, our services include purchasing of raw materials, production, packaging and quality control.

Through this flexible approach, we are able to integrate perfectly into supply chain for solid dosage forms. Monitor and optimize the timeliness of our delivery and keep it up to our customer's full satisfaction.

Our expertise in the pharmaceutical industry with highly integrated production facilities comes the capability to manage a flexible production line. This empowers us with the capability to undertake contract manufacturing projects.

We offer flexible terms of trade with individual attention to each customer. We solve the challenges of working with an extended design chain so as to facilitate a productive & profitable outsourcing partnership for our customers.

We capture and process all the product definitions provided by customer's information through a secure online environment that makes a convenient setting for sharing information. Secure and easy, this system allows for customers to easily share information internally. Also, we invite partners and suppliers to view work with information-with as many access barriers as they choose to keep.

Indu Regulatory Services (IRS) will complement your organization to provide diverse regulatory solutions, including diverse product profiles and submissions for review and endorsement by the authorities such as FDA and other International Regulatory Authorities.

We assist in retrieving various legal documents from Local FDA:

• Loan License
• WHO-GMP Certificate
• Product Permission
• Certificate of Pharmaceutical Product (COPP)
• Free sales certificate

Our packaging design specialists will help you in the development of packaging to suit your individual product(s). From initial concept through production, we take charge of your packaging design project.

Our creative packaging designers and production resources use years of design experience to provide you with superior service and value. Our team offers you package and display ideas that will grab the end users' attention and motivate them to buy your products.

We provide a specialist service of precision driven artwork origination and print-ready files for any type of pharmaceutical primary and secondary packaging, which include the following:

• Folding boxes / cartons
• Patient information leaflets (PIL) / Package Insert
• Booklets
• Label
• Blisters
• Tubes
• Sachets
• Pouches and outserts
• Posters & Banners

Apostille Services:

If the document emanates from a country that is party to the Hague Convention on legalization 1961, an apostille is attached to the document, usually by a government official. The attachment of the apostille is what legalises the document.

WHAT DO WE DO?

Indu Regulatory Services (IRS) provides expedited solutions for Apostille and Embassy or Consular Legalisation of Export & Legal documents for international use.

WHAT IS LEGALISATION?

Legalisation simply means confirming that a signature, seal or stamp appearing on adocument is genuine.

Legalisation of Foreign documents. Often legal documents that emanate from one country for use in another country require ¨Legalisation¨. This process is unfamiliar to many, and is often confused with ¨apostille¨and notarization. Legalisation is essentially the process of authenticating a legal document.