Mknal Global Solutions

Mknal Global Solutions

Kalyan West, Mumbai, Maharashtra
08046074246
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Company Factsheet

Nature of Business
Consultants

Total Number of Employees
Upto 10 People

Annual Turnover
Upto Rs. 50 Lakh

mKnal Global Solutions is a consulting company engaged in providing Pharmaceutical, Information Technology (IT) and Engineering services to Pharmaceutical Healthcare, Medical Device and Diagnostic, Biotechnology industry.

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Products & Services

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Engineering & Industrial Design

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mKnal’s Engineering team has been providing Industrial Engineering Design, Project and Construction Management Services to Pharmaceuticals and API sector for the past 18 years.

Today, we feel proud to have completed several projects, which are now, award winning and internationally approved facilities that produce high quality products & services efficiently and economically to global markets.
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Clinical Development, Bioavailability, Bioequivalence

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We design, conduct and manage Clinical studies from Pharmacokinetic, Pharmacodynamic (Phase-I) to Bioavailability /Bioequivalence for EMEA, USFDA, TGA, MCC, & Latin America markets.

Clinical Research Services.
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Medical Writing

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mKnal Global Solutions has been providing medical writing services to many of the Europe based pharma companies.

These includes:

1. Module 2 (Clinical & Non-Clinical Overviews i.e. Module 2.4 and Module 2.5 writing)

2. Summary of Product Characteristics (SmPC) Translation

3. SmPC Comparison

4. Scientific and Medical Writing for Regulatory Authority Discussion

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Pharmaceutical Information Technology (IT)

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The Information Technology (IT) team of the company has been instrumental in providing solutions to enhance the efficiency and management constraints of various areas including Human Resource Systems, Maintaining Documentation and Batch Records, Dossier Compilation, etc.
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Medical Device & Diagnostic

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Our Medical Device arm is certified to ISO 13485 - this assures that you are receiving standardized quality products. Our design and development procedures comply with ISO 14971 standards for Risk Management. We offer quality which is at par with US FDA QSR & CE requirements and trust worthy.

Our specific services range from Concept generation to Clinical trials, making us your one source for complete medical devices development.
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Analytics, Pharmacokinetics, Bio-Statistics & IVIVC

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mKnal Global Solutions has been instrumental in constructing IVIVC simulation studies for successful bioavailbility and bioequivalence studies. Some of the recent ER/IR combination products has been successfully executed using this approach.

Estimation of Sample Size, Study Design and indepth analysis of the Pharmacokinetic to evaluate the formulation performance has been key to success for many of our clients.

In-vitro In- Vivo Co-relation (IVIVC) studies to increase the success rate of the formulation and save cost on the biostudy.
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Quality Assurance, Medical Monitoring & Auditing of BA/BE

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An independent quality assurance team comprising of trained and rich experienced professionals on every aspect of product development performing audits, compliance assessment and monitoring of clinical studies.

Monitoring and Auditing of Bioavailbility and Bioequivalence studies.

Experience working on Pharmacokinetic, Pharmacodynamic studies. This includes various dosage forms including Orals Solids and Liquids (Tablet, Capsules, Suspension, Syrups, Solutions, etc.), Injectables (Emulsiuon Based), Transdermal Patches, Chewing Gums, etc.

GMP Audits, GCP and GCLP Audits.
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Generic Product Development

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mKnalGlobal Solutions provides services to small and medium size Generic Pharmaceutical Companies on Generic Product Development from API sourcing till complete ANDA dossier submission for USFDA, MHRA, EU, TGA, MCC, ANVISA regulatory authorities.

mKnal undertakes complete product portfolio/program management of generic pharma companies from Europe, United States, Australia, Latin America; where we accomplish complete dossier development in association with our trusted partners.

We design, conduct and manage Clinical studies from Pharmacokinetic, Pharmacodynamic (Phase-I) to BA /BE for EMEA, USFDA, TGA, MCC, & Latin America markets.
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Mknal Global Solutions A1-602,Kalyan West, Saket Paradise, Kalyan West,
Mumbai-421301, Maharashtra, India

Kunal Khismatrao ( Owner )
08046074246Call Response Rate: 50%
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