A Leading Regulatory Services Company
RBridge is a consulting company which provides regulatory guidance and quality compliance services to various manufacturers in the healthcare industry. We work together with various companies which deals with Pharmaceuticals, Medical Devices, APIs and Intermediate, Chemicals, Food, Cosmetics, Neutraceuticals, Phytopharmaceuticals and Herbal products. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications. Our approach is integrated and we plan the regulatory strategies considering long terms vision of our customers. We serve the customers across the globe for India registrations and oversees approvals.
Certificate of suitability Submission
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Publishing & Submissions
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Regulatory Services
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Compliance, Audit and Validation
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Regulatory Intelligence
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Regulatory Medical Writing
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Strategy Planning
Selection of Countries for the Registrations of Dossiers in different markets (Regulated and Semi-Regulated ). Strategic submission to developed countries, to reduce time-lines for placement of products into export.
Pre-Registration And Registration
We offer our services for data generation, regulatory and quality compliance services with gap analysis and expert reports in line with the regulations of the specific country and facilitating successful registration of Products Globally.
Global Regulatory Services
We provide end to end support to our clients for entry into the global markets We provide complete product life cycle management, starting from strategizing of products for specific markets, preparation and filing of appropriate documents to the Health Authorities of Regulated and Semi-regulated and ROW markets and post approval changes.
OUR SERVICES
Drugs
RBRIDGE Lifesciences Pvt Ltd specializes in dossier strategy, dossier gap assessment, dossier compilation, validation and final submission of various new product authorization applications.
Medical Device
Medical Devices are one of the most important sectors in healthcare. With advancing technologies and rapid innovations medical devices are one of the fastest growing industries.
CRO
A contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
Cosmetics
Cosmetics market in India is growing at a rapid pace. The demand for cosmetics products has been growing, particularly in urban centres owing to several factors.
In-Vitro Diagnostic Kit
India regulate Import, Manufacture, Sale, Distribution and Clinical Performance of In-Vitro Diagnostic Medical Devices under Medical Device Rules 2017, w.e.f 1st January, 2018. Diagnostic kits manufactured in India require to obtain the license from State Licensing Authority (SAL) / Central Licensing Authority (CLA).
Biological
Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism).
Food Regulatory Service
Regulatory Services on Food, Health Supplement, Nutraceuticals, FSMP and FSDU. Product Compliance Assessments,Product development support,Labelling support, Approval of Non-specified food and food ingredients,Regulatory guidance etc.
Our Directors
Maya is passionate Regulatory affairs professional with 11+ years of experience in pharmaceutical and Medical device. She is certified Lead Auditor for ISO 13485 Quality Management System for medical devices.
She has done her Masters in Pharmacy from Uttar Pradesh Technical Institute, at Greater Noida area.
As regulatory affairs professional, well versed with regulatory strategies for USA, Europe, Emerging Markets, domestic market requirements. As a professional, she has handled more than 55 EU Marketing Authorisation original submissions as well as life cycle management for more than 150 Marketing Authorisation.
She is well versed with, drafting, compilation and submissions for variety of emerging markets.
Knowledge and understanding of registration requirements of Indian Medical Device Rules (MDR) 2017.
Maya is passionate of eCTD dossier compilation and reviewing.
CTD / eCTD/ ACTD / Country specific format in submission for EU/ Brazil / MENA / ASEAN Countries/South Africa, South Korea and Hong Kong.
Communicating with Global Marketing persons for dossier registration and to resolve the issue piled up during the process of registration and re-registration.
Maya is one of the promoters and directors on Rbridge Lifesciences Pvt. Limited.
She would be handling major role of business development and customer networking for the company.
With unique coordinating and collaboration skills, she would be an asset of the Rbridge.
Santosh is Regulatory affairs & Quality compliance professional with rich 26 years of experience in the pharmaceutical industry. He had worked with top Indian pharma companies like – Cipla, Unichem, Glenmark, Alembic, Emcure, Bluefish. After 24 years of corporate career, Santosh started his career as a freelance regulatory and quality compliance service provider.
Active in providing services to small and medium scale pharma companies and offering career counselling to pharma fresh graduates at Pharmacy colleges at Pune and Mumbai.
Quality compliance auditor for drugs and pharmaceutical and Medical devices industries. Offering services within Vendor and GMP Audits, ISO13485 Third Party audits for Medical Devices, Quality compliance.
Santosh is experienced regulatory strategist for markets like USA, Europe, Canada, Australia & emerging Markets and domestic Indian markets.
As a regulatory professional Santosh has exposure and hands on experience in marketing authorisation dossier compilations and submissions vs ANDA. MAA as per Europan procedures. Liaisoning with CDSCO/ DCGI zonal and central offices.
He is one of the Advisor directors of Rbridge Lifesciences Pvt. Limited.
Savio is a skilled Result Oriented Professional having 39+ years of experience in Quality (QA & QC) in Organizations approved by various international regulatory bodies including, USFDA(USA), MHRA(UK), TGA(AUSTRALIA), HEALTH CANADA(CANADA), ANVISA(BRAZIL), MCC(SOUTHAFRICA), WHO(Geneva), INVIMA(COLUMBIA), CDSCO (INDIA) and Ministries of Health of various other countries and proven track record of success in administering Quality Systems.
Expertise in Co-ordinating Quality Control (QC) Testing, improving QC procedures and streamlining Manufacturing through the creation and implementation QA procedures and systems.
In depth knowledge of Current Good Manufacturing Practices (cGMPs). As per various International Regulatory, Corporate Guidelines and application of same to ensure compliance at all levels of Manufacturing and Quality Operations.
Expertise in conducting Audits (Internal, Customer and Vendor) as per ICH/INDIAN/US/EU GMPs (SCHEDULE M/21CFR Part210&211/EUDRALEX Vol 4/ WHO) and close out of the same based on review of Root Cause Analysis and effective CAPA.
Proven Leadership Skills with the ability to provide guidance and mentorship to junior staff to achieve business objectives and manufacturing goals.
He is one of the Advisor directors of Rbridge Lifesciences Pvt. Limited.
Ashok Tulankar is a competent professional with 36 years of rich experience in Production Planning & Control, P.D.Lab., Quality Inspection & Compliance.
Functional expertise in managing the production operations with key focus on bottom line profitability by ensuring optimal utilization of resources. Well versed with the ICH Q7A/ Q8A & USFDA regulations and handled USFDA, MHRA, EDQM & WHO inspections CGMP audits.
Adept in handling technical due-diligence, quality & compliance, site monitoring, management of business negotiations, product transfer and supply of high quality products. Possess in-depth understanding of ISO standards & implemented standards without any non-conformance.
Proficient in conducting Safety Audits, HAZOP Studies, Risk Analysis, Fire Investigation, In-plant Training & Seminars for industries such as Chemical, Petrochemical, Refineries and Engineering. Possess a clear understanding of the industry, technology trends with the distinction of instituting quality control techniques to achieve product excellence at the lowest overall cost. Excellent communicaton & relationship management skills with demonstrated abilities in problem defining, solving technical and commercial issues & mentoring motivated teams.
Diligently served as the visiting faculty in NITIE, NSC, College of Insurance, DGFASLI and Labor Studies, National Safety Council NIA, UDCT (Mumbai University) DIFR, Delhi, Institute of Fire and Engineer and IIT, Mumbai.
He is one of the Advisor directors of Rbridge Lifesciences Pvt. Limited.
Dr. Prakash Kolhe is a competent professional with 36 years of rich experience in Production Planning & Control, P.D.Lab., Production Compliance. Functional expertise in managing the production operations with key focus on bottom line profitability by ensuring optimal utilization of resources. Well versed with the WHO API Regulations, FDA GMP and EU GMP Part II and PIC/s API GMP regulations. Handled USFDA, EDQM & WHO inspections CGMP, Mexico audits. Handling technical due-diligence, compliance, site monitoring, management of business negotiations, product transfer and supply of high quality products.
Possess in-depth understanding of ISO standards & implemented standards without any non-conformance. Environmental Clearances and Hazard analysis…
API Process Investigation and Development for Cost Rationalization.
Technology Transfer Expertise
Thorough API Quality Attributes and well versed with Synthetic and Semi-synthetic Manufacturing Process Validation
API Facility and Product – Project Management and Timely Execution. Support for the Contract Manufacturing, Supply chain management. Regulatory & GMP Compliance. Complete Factory Administration & Management
Budget Preparations / Process Capabilities. Cost saving and Life cycle and change management for the legitimate changes.
He is one of the Advisor directors of Rbridge Lifesciences Pvt. Limited.
Mr. Vinayak Mhatre has 26 Years of experience in Quality Control, Quality Assurance and Analytical Development at Indian Generic Pharmaceutical manufacturers, approved by USFDA, MHRA, TGA, WHO, other PIC/s authorities etc. As an employee – Was associated with Indian companies like Cipla, Watson, FDC, Wockhardt.
As a consultant – Associated with pharmaceutical companies for Inspection remediation plans, activities, like… GSK Nashik, Megafine Pharma Pvt Ltd, Wockhardt Ltd, Harman Finochem and many other…
As a Technical trainer for pharmaceutical GMP, GLP, Data Integrity, QMS, OOS, Laboratory systems, grooming of staff, technical report writing, Analytical data review and other technical topics.
Active participation and leadership in the remediation activities as follows during import alert by USFDA for few pharmaceutical companies
Involvement in OOS and analytical incidents investigations including review, technical report writing, CAPA and trending to reduce the number of laboratory failures and to improve productivity.
Involvement in data integrity review including hard copy and soft copy of laboratory data for release and stability testing (Including instrumental and chemical analysis data)
Active involvement in compliance submitted towards observations from TGA / Health Canada for a reputed Indian API manufacturer (Refer achievements and expertise below)
Exposure to Quality Control and Quality Assurance functions of API and various finished dosage forms like Tablets, Capsules, Liquid Orals, Nasal preparations, Topical preparations, Oral Rehydration Salts, Dry powders for oral suspensions, Ophthalmic preparations.
Worked with companies engaged in manufacturing of formulations / API with therapeutic Categories like Cardiovascular, Anti-diabetic, Anti-inflammatory, Antifungal, Anti-malarial, Antibacterial, Antibiotics, Anti-hypertensive, Antiparkinson
Conducted Training Programmes on OOS, GMP overview, Deviations, Change Management, Stability, Good documentation practices, Data integrity, Good distribution practices in few reputed pharmaceutical companies / institute.
He is one of the Advisor directors of Rbridge Lifesciences Pvt. Limited.
INDIA REGULATORY SERVICES
RBRIDGE Lifesciences Pvt Ltd specializes in dossier strategy, dossier gap assessment, dossier compilation, validation and final submission of various new product authorization applications. RBRIDGE Lifesciences Pvt Ltd Regulatory Affairs team has expertise in compiling and submission of following
Guidelines
Control of Nitrosamine Impurities in Human Drugs
Guidance for Industry
GLOBAL REGULATORY SERVICES
Our Growth
In less than decade, Metina has grown exponentially in varied technical services starting from regulatory science to quality certifications for the manufacturing sites. Metina has advanced further by developing internal expertise for Biosimilar products development and trained pharmaceutical professionals in technical area.
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Our Clients
About
A full Portfolio of Capabilities to deliver Measurable Results for clients Regulatory affairs Market intelligence and filing strategies. Regulatory filings at USA/ EU/ Emerging Markets Emerging Market Tender activities and support to participate thru capable distributors & facilitators
Services
- Drugs
- Medical Device
- In-Vitro Diagnostic Kit
- Food Regulatory Service
- Cosmetics
- Biological
- CRO
Contact
Rbridge Lifesciences Pvt Ltd
- info@rbridge.in
- maya.singh@rbridge.in
- 7977768788