About Inorim Lifesciences

Inorim (Innovative Methods & Ideas For Regulatory, IPR, Pharmacovigilance (PV) and Market Research...) Life Sciences   is one of the ISO certified Regulatory, IPR, Pharmacovigilance (PV) & Market Research Consulting & Training Organization for the Pharmaceuticals, Biologicals, FMCG, Herbal, Cosmetics, Medical devices and Narcotics & Psychotropic industry. Mrs. Karishma S. Patil & Mr. Sunil N. Patil founded it in 2019. We assist in regulation compliance, IPR Filings, PV activities and market research solutions of healthcare products such as Medical devices, API, Pharmaceuticals, Phytochemicals, Biologicals, Herbals and Nutrients. Most importantly, Inorim Life Sciences is designed to support Pharmaceutical Industry, Pharmaceutical profession and continuing education toward regulatory affairs, Intellectual property, pharmacovigilance and Market research.

Our Services

Dossier Preparation, Review & Maintenance

• Dossier in CTD (modules 1 – 5 or any requisite module) and eCTD formats for worldwide markets like EU, USA, UK

• Preclinical and clinical Overviews / Summary writing based on literature search / Published studies / articles from journals.

• Dossiers for ASEAN and ROW countries in ACTD/ as per country specific format, for any dosage form.

• Dossier reformatting to CTD / eCTD by taking up gap analysis of existing dossiers in line with current requirements.

• Product information update (SmPC, PIL and Labelling).

• Preparation of Drug Master File and Certificate of suitability (open and closed part)

• We will evaluate your technical data through all stages of the development process, review study protocols and conduct due diligence on your behalf.

• Handling of all types of variations (Type Ia, Ib and II), annual reports, renewals of MAAs and support in query responses

• DMF for bulk drugs

• Dossier gap analysis and review for formulations and bulk drugs

• ACTD, CTD & eCTD dossiers preparation and maintenance for Regulated and Rest of the world

• Documentation review and analysis

• Annual Product Review

• Report writing

Compliance

• GMP compliance

• Quality compliance

• GLP compliance

• Regulatory compliance

GMP

• Writing of QA, QC, Production, R&D and Corporate QA SOP’s

• Review and revision of existing SOP’s

• Audit to identify need for new SOP’s and prepare new SOP’s

• Preparation and review of packaging material and raw material specifications

• Preparation of quality manual and Policy for the company

• Preparation of Safety, health and environment related SOP’s

• Review existing MFR’s and revise to meet regulatory requirements

• Preparation of annual product review and trend analysis

• Preparation and revision of Site Master File

• Preparation and revision of Validation master Plan

• Review and revision of protocols for various types of validations

• Process Validation

• Analytical validation

• Cleaning validation

• Protocols for DQ, IQ, PQ and OQ for equipments

• Other GMP documents

• Review of documents and approvals from regulatory agencies to identify gaps and non-compliances

Quality

• Policy, SOP & MFR, BPR Review, Preparation & Optimization

• Quality System (QS) Development, Assessment & Optimization

• Root Cause Investigations & Corrective & Preventive Action (CAPA) Planning & Execution

Training

• Quality

• GMP

• Workshops

• Business skills

• Mentoring and Coaching for Students/Pharma Professionals

We pride ourselves in serving basic IP needs like Patent Search, Trademark, Copyrights, of businesses of varied sizes and structures with accuracy and swift turnaround time in offering creative solutions to most complex legal and techno-legal issues.

• Intellectual Property Management Development Programme & Workshops

• Patent Search Services

• Freedom to Operate reports

• Patent Watch

• Patent Mining and R&D Coordination

• Patent Expiry Status Report (Worldwide)

• Patentability Consultancy Trademarks, Copyright & Designs

InoRim Life Sciences’s market research & consulting services helps its clients identify new market opportunities, growth engines and innovative ways to capture the market share.
Our experience in healthcare market research sector includes concept tests like future trends in Pharmaceuticals, marketing strategies for setting up day-care centres, feasibility for setting up medical malls, strategy development for growing pharma organizations for improving the health and attracting premium customers.
This study involves in-depth interviews with General Physicians, Specialists, Medical Administrators, Hospital Administrators, Distributors and Retailers.

For instance, to identify a new business opportunity, we first understand its clients’ strengths, weaknesses and expectations. The industrial horizons are then scanned so to speak, nationally or globally. These short listed opportunities are investigated to verify whether they are relevant to our clients.
For new opportunity areas, each opportunity is thoroughly investigated quantitatively and qualitatively so that our client has a complete picture as well as flavour of the opportunity – both existing and emerging.

Quality Ethics

Quality – to deliver only quality in whatever we do
Integrity – to set the highest standards of integrity being cherished by its clients
Confidentiality – to raise the standard of data security and compliance to the uppermost level in the industry.

Market Research we do

Primary Research

Through our constant approach on growing medical professional’s panel, we are setting standards for healthcare projects through quality delivery. We facilitate Primary Research with our expertise in Qualitative and Quantitative Research.

Secondary Research

The quality of our secondary research solution is known in healthcare-consumer segment. Our trusted options of public, commercial and educational sources have proved to be useful in Social Media Audit, Media analysis and Media Monitoring.

 

We help manufacturers overcome the barriers in preparing dossiers for filing applications for various registrations. Our constant guidance, thorough follow up and other services like clinical trial management, medical writing, BE etc. enable our client to obtain successful registrations and apply for licenses.

Our expert handles all documentation related to FSSAI, import assistance to help in licenses with continuous follow up. Food Regulatory Services Over the years, through careful monitoring of changing laws and liaison meetings working with apex regulatory bodies, we at InoRim Life Sciences have developed an in-depth understanding of the rules and guidelines set by the FSSAI.

The cosmetic registration process requires proper planning and review of all ingredients and labeling for registration in India. The cosmetic application should clearly define the products in respective categories. We provide services for several product registrations and certifications, we are the regulatory partner you need with you through the entire process in completing the registrations.

Medical device registration, Import license, Application to CDSCO, Performance evaluation, etc. Medical Devices have always been an object of concern and regulation by the Regulatory bodies and Government. Regulatory bodies classify medical devices based upon the associated risk and have defined relatively easy procedures for license applications. Similarly, the government for the import of medical devices has promulgated rules and guidelines. With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect. Medical devices classified as A, B, C and D classes and governed by respective central and state regulatory authorities.

Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for LVP, Serums, NOC for Vaccines, etc. 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.

Manufacturing license, Narcotic and Psychotropic Drugs, Export NOC/Certificate, Import NOC/Certificate, NOC for Import. Narcotics include drugs 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.

Import of Phytopharmaceutical Drugs, Manufacture of Phytopharmaceutical Drugs Phytopharmaceuticals still the mainstay of about 75 - 80% of the world population, mainly in the developing countries, for primary health care. This is primarily because of the general belief that herbal drugs are without any side effects besides being cheap and locally available. According to the World Health Organization (WHO), the use of herbal remedies throughout the world exceeds that of the conventional drugs by two to three times. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants, which contain as active ingredients plant parts or plant material in the crude or processed state. Regulatory affairs and clinical trials should made on herbal drugs to improve their availability.

Our experts undertake a variety of market research projects within the medical and pharmaceutical market. We conduct researches among doctors and other medical staff, pharmacists, patients, hospital managers and opinion leaders. To ensure superior service quality, we cooperate with medical consultants, while adhering strictly to research ethics and data protection standards. In the area of pharmaceutical market researches, we have run projects for manufacturers of OTC and Rx drugs, as well as drugs under development and medical supplies. The most common types of Pharmaceutical market researches:

• Patients’ opinions and habits,

• Physicians’ therapy and prescription habits,

• Pharmacists’ recommendations,

• Satisfaction studies (e.g. cooperation with medical representatives),

• Name, packaging and advertising concept testing,

• Research into pricing and reimbursement schemes,

• Pre-market launch studies.

Adverse event reporting based on literature search Summary of product characteristics (SmPC), Pack insert (PILs) and PSUR writing/updation.
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Training Sessions

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Happy Professionals

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Years Experience

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