Regulatory Services

TOU PHARMA BIO is one of the well-respected and prominent Regulatory Consulting Organization for the Pharma bio-sciences industry.  It was founded by visionary Dr. Habibuddin M Ph.D. (Pharmacy). TOU PHARMA BIO is the pioneer Regulatory Organization for assisting in regulatory compliance of healthcare products such as Pharmaceuticals, API, Biologicals, Herbals, Nutraceuticals, Phytochemicals, Medical devices.  Most importantly, TOU PHARMA BIO is designed to support the Pharmaceutical Industry, Pharmaceutical profession and continuing education toward regulatory affairs.
Enabling life sciences organizations to meet their Regulatory goals across the globe for Pharma, Generics, Biosimilars, Vaccines, Cosmetics, OTC, Nutraceuticals/Food and Dietary Supplements, and Medical Devices, Tou Pharma Bio offers a full spectrum of end-to-end Regulatory services that span across a strategy to submissions and lifecycle maintenance.

Out sourcing

To reduce  investment level.

• Frequent changes or updates need to install.will attract significant cost of up to 20% of software billing amount.
• Specialized systems require trained manpower, companies need have to shell out extra bit of money on training existing staff with new systems or look to hire trained experts 
• Payback period on the investment can be very lengthy for Small companies who have less than 10 submissions annually.
• Outsourcing has been the BUZZ  word ,  with so many companies outsourcing many processes to cross countries, cities and within cities also. Outsourcing has always helped in reducing 2 things

 "TIME  & MONEY"

It is  logical to outsource,  companies can concentrate on their core competency, in the case of eCTD outsourcing, it ticks all the right boxes Logical, Money and time saving.

• 1) No need to make any upfront investment in the technology, you are only paying for the service in short you are only paying for manpower thereby saving a lot of capital which can be used for R & D activity.
• 2) No Need  to worry about breakdowns and heavy Annual Maintenance contracts and frequent FDA updates on the systems so it’s a big plus over there.
• 3) Outsourcing works on Pay as you go basis so you are paying only for actual submission you make in a year so if you don’t plan any submission you don’t pay anything.
• 4) No  need to train or hire eCTD experts in your company reducing your company’s permanent employees and saving on HR expenditure. Companies with less than 10 submissions in a year will be the biggest beneficiary of this model.

Services

• Global Market Analysis
• Regulatory Consultation
• Market Access and Regulatory Strategy
• Regulatory Intelligence
• Publishing and Submissions
• Regulatory Labeling
• Artwork and Pack Management
• Regulatory Medical Writing
• Safety and Pharmacovigilance
• Audit and Validation
• Health Authority Interaction
• Product Registrations and Market Authorizations
• Lifecycle Management/Post Approval Activities
• Local on-the-ground Presence
• Regulatory Centralization

Common Technical Document( Product Dossier) is an integral Part of any registration application for Marketing Authorization. Dossier in CTD Format/ ACTD Format or local country format is submitted to Food & Drug Authority or Ministry of health or any other equivalent authority along with other required technical documents and legal manufacturing permissions.

TOU PHARMA BIO can help you prepare an entire technical document for drug product registration in various countries all over the world.

TOU PHARMA BIO Provides following consulting service in regards to Technical Document.

Dossier Compilation and writing as per CTD Format – Common Technical Document

Module 1 – Administrative Information  Common Technical Document
Module 2 - CT Overview
Module 3 – Drug & Product Part /CMC
Module 4 – Non-Clinical
Module 5 – Clinical
CTD Format Dossier is widely used in a semi-regulated & regulated market like CIS Countries, Middle Eastern countries, European Union, USA, Australia, Canada, Japan, etc

Dossier writing and compilation as per ACTD Format – Asian Common Technical Document

Part I – Administrative Documents
Part II – Quality Documents
Part III – Non-Clinical Documents
Part IV – Clinical Documents
Pharma Consulting - Technical Document

ACTD Format is Asian harmonization for Common Technical Document used in Asian Countries like Vietnam, Thailand, Singapore, and Malaysia etc.

We can help you compile and write an entire technical document or specify modules as per your request, we also help companies establish their Document Management and technical writing system by guiding them with draft templates on BMR, COA, MOA, and other technical documents. We customize the same as per company requirement – Good for startup companies or scale up companies.

Why work with us???

Over 24 Years of Industry Experience
Well Qualified Team  

Medical Device Facility Registration with US FDA & Health Canada
Annual Reports & Amendments to US Drug Master Files & Health Canada
US DMF holders are required to submit ANNUAL Reports for their submission to keep their submission in Active Mode.
TOU PHARMABIO Help Companies comply with such requirement by assisting them with  Filling Annual Reports for DMF holders to US FDA Annually on their behalf. ( Type I , II, III , IV & V)
Amending Existing DMFs ( Type I , II, III , IV & V)
Re Activating In-active US DMFs.
US Agent requirement for FDA Purpose.
Compilation and Submission of DMFs for Health Canada 

Regulatory Medical Writing

Medical writing for pharmaceutical industry involves regulatory documentation for regulatory agencies all over the world. Our experts work with a clear vision and their work clearly demonstrates safety and efficacy of the product with our medical writing.  TOU PHARMABIO expertise in regulatory medical writing can assist companies with the following services.
Medical writing for Module 5 – Clinical Documentation
Medical Writing for Module 4 – Non Clinical Documentation
Module 2.4 to Module 2.7 – Overview & summaries

PSURs Reports – Periodic Safety Update Report now called PBRER – Periodic Benefit- Risk Evaluation Report
    Pharmacovigilance System Setup
    Risk Management Plans
    Summary of Product ( SPC), Pack Insert

•     Development of Application & submission File
•     Product Assessment & identifying of Predicate
•     Designing test requirements of the Products

•           Writing the Master file
•           Establishing Labeling requirement as per US FDA
•           Designing the Claim and broucher with the help of the client
•           Submission & Review of 510K
•          Verification of 510K Submission file

•          Completing the file and making application for 510K
•          Coordinating fees with US FDA for application
•           Post Submission & Query Handling

• Getting Final clearance for sale of medical device
• Training your personnel for US FDA requirements , Audits
• Implementing GMP & Quality System in your Plant as per US FDA requirements