Dossier Development

Dossier Development @ THINQ Pharma-CRO Limited Research

THINQ Pharma-CRO Limited is engaged in Dossier Development for highly regulated markets like US, EU, Australia, New Zealand, South Africa, Brazil, Mexico and emerging market like Commonwealth of Independent States (CIS countries), Latin America and MENA Countries (Middle East and North Africa). The scope of work for Dossier Submission includes API Sourcing, API Characterization, Formulation Research & Development, Analytical Research & Development, Packaging development, Scale up and Exhibit batch Manufacture, Stability Studies, Technology Transfer and Documentation.

Formulation Research and Development @ THINQ Pharma-CRO Limited Research

Core Competencies
THINQ Pharma-CRO Limited undertakes contract formulation development of Generic (Prescription & OTC), NCEs and proof of concept products (505(b)2 & Hybrid) of various dosage forms, aided by state-of-the-art technology and equipment. Formulation designs include:

To develop proof of concept and create position by proactively patenting technology
Ethical Products
Veterinary Products
Efficient Project Management
To develop non-infringing (NIF) strategies, patent drafting, filing and coordinating with IP agents and attorneys

Scope of Work

Literature Information & Primary Patent Status Evaluation landscaping and development strategy.
Prototype Formulation Development in compliance with latest regulatory guidance such as ICH Q8 QbD.
Packaging Development
Scale-up of selected Prototype Formulation
Process Optimization through QbD (ICH Q8)
Process Validation
Manufacture of Exhibit/Bio-batch
Bioequivalence Study
Product Development Report
Documentation in CTD Format
Technology Transfer
Stability Study

Analytical Research and Development @ THINQ Pharma-CRO Limited Research

Ultra modern facilities and instruments boosts THINQ Pharma-CRO Limited the confidence to handle Contract Research conforming to cGLP norms. Analytical Services fully support Formulation Research and development process with a team of experienced analysts.

Core Competencies

GLP facility to support your R&D needs
Photo stability with humidity chamber
Characterization of API, Excipients and Drug Product
Dissolution Profiling
Residual Solvents analysis in API and Drug Products
Contract Stability Services as per ICH guideline
Stability Indicating Method Development and Method Validation
Stability Protocol Preparation, Analysis & Monitoring
Assigning Shelf-life

International Regulatory Affairs @ THINQ Pharma-CRO Limited Research

Our Service includes Developing Regulatory Strategies, Comprehensive Documentation, Submission and Archiving of Documents. Regulatory Department also oversees the compliance program, ensuring that all practices conform to the constantly changing regulatory requirements.

Core Competencies

Preparation and Submission of Drug Master File (DMF)
Preparation of Site Master File (SMF)
Generation of Dossier as per European Union and US Guidelines
Pre-Inspection Audit
Assistance for getting Certificate of Suitability (CoS)
Reply to Queries
Writing Expert Reports

Quality Assurance @ THINQ Pharma-CRO Limited Research

A dedicated QA team ensures world class quality by continual upgradation in systems. All our R&D activities navigated by QA procedures. The Scope of work covers the following:

Document management system
Standard Operating Procedure
Customer meeting and training programme
Change Control System
Review and evaluations of Master Formula Card, Validation Protocols and Reports.
All necessary controls on starting raw materials, intermediate products, bulk products, in-process quality controls, calibrations and validations.
Safety policy
Environment policy

Infrastructure @ THINQ Pharma-CRO Limited Research

THINQ Pharma-CRO Limited India:
Total Floor Area: Approx 5000 sq. feet ,Brooklyn Tower 11th floor.

Formulation and Development: 2000 sq. feet
Analytical Development: 2000 sq. feet
Regulatory Affairs, DQA and IPR: 500 sq. feet
Support Services - HR/Admin/IT: 500sq. feet

Infrastructure: Formulation Development @ THINQ Pharma-CRO Limited Research

The Formulation Development Laboratory has all the modern equipment that are required for product development study. THINQ Pharma-CRO Limited is committed to regularly upgrade the existing technology available by procuring latest Instruments and Equipment available in the market.

The Formulation Development lab has the following equipment:

Mechanical Sifter
Rapid Mixer Granulator
Fluid Bed Dryer
Fluid Bed Processor (with bottom spray)
Cage/Octagonal Blender
Rotary Compression Machine - GMP Model
Auto Coater
Reverse Laminar Air Flow
Stability Chambers
Photostability chamber with Humidity control
Planetary Mixer
Mechanical Stirrer and Homogenizer
Sieve Analyser
Halogen Moisture Analyzer
Disintegration tester
Friability test apparatus
Hardness Tester
Capsule filling machine

Infrastructure: Analytical Development @ THINQ Pharma-CRO Limited Research

The Analytical Development Laboratory has all the mandatory requirements. It complies with the cGLP.

The Analytical Development lab has the following equipment:

High Performance Liquid Chromatograph with Auto sampler, Quaternary gradient, Diode array, UV, Fluorescence and Refractive index detector
Gas Chromatograph with Head Space
Dissolution Apparatus with Auto Sampler and UV Spectrophotometer
Dissolution media degasser
UV/Vis Spectrophotometer
Fourier Transform IR Spectrophotometer
Digital Analytical Balances with varied capacity
Auto Titrator
Sample Dilutor
Water Purification System
TLC Spotter
BOD Incubator
Laminar Air Flow
Melting Point Apparatus

Infrastructure: Database and IT @ THINQ Pharma-CRO Limited Research

The Formulation Development, Analytical Development and Regulatory Affairs are well-connected with the recent progress of each and every product through LAN. There is an internal ERP programme and an Internal Software programme describing the stage, timelines and constraints of each and every project. Periodic meeting is held during which the project status is discussed.

Each and every Project can be accessed easily through E-mail for knowing the progress of the Projects.

Our dossiers can be viewed on the web for evaluation upon request.

Infrastructure: Facilities - Tie ups @ THINQ Pharma-CRO Limited Research

We, at THINQ Pharma-CRO Limited believe that Quality is built up in the product at various stages, right from the API sourcing to the submission. Though we are a Pharma CRO we involve ourselves in all the area related to Pharmaceutical products. We feel our search in achieving quality product is not restricted to Product and Analytical Development, so we have joined hands with the best quality counter-parts like API Manufacturers, Contract Manufacturers and Clinical CROs. After all "TOGETHER WE CAN SERVE THE BEST".

Tie-up with API Suppliers
We have tie-up with leading Bulk Drug Manufacturers in India. Our tie-up is not only with Indian Manufacturers but also with some International API Manufacturers.

Tie-up with Clinical CRO
We have an association with one of the leading clinical CROs involved in conducting BA/BE Study. It is ANVISA approved and has a team of highly experienced Medical Professionals.