Zenith Regulatory Service

Drug Master File (DMF)

Drug Master File (DMF) Compilation for open and closed part.

Drug Master File (DMF) is a master document containing

complete information on API.

It is a submission to FDA covering factual and complete information on its chemistry, stability, purity, impurity profile, packaging and cGMP status of any API.

We also perform the following studies, in co-operations to DMF preparation:

Structural Elucidation Studies (Elemental Analysis, IR, Mass, NMR C & H, XRD, DSC), Analytical Report (COA)

Analytical Method Validation

Process Validation Stability data studies

Determination & Validation of Potential Impurities & Solvent Impurities

We have tie-ups with well established labs (NABL Certified) to carry out such analytical testing. (All the

data supported by necessary Chromatograms & Spectrums).

Zenith Regulatory Service Preclinical / Non clinical / Toxicological Studies Studies in which a drug is tested on animals and in other non-human test systems. Safety information from such studies are used to support an investigational new drug application. The main goals of pre-clinical studies (also named animal toxicology and nonclinical studies) are to determine a product's ultimate safety profile. For instance, drugs may undergo pharmacodynamics (PD), pharmacokinetics (PK), ADME, and toxicity testing through animal testing. Our associate animal toxicological study centers are providing preclinical studies services to fulfill requirements of registration dossier. Toxicity Studies: Acute Toxicity

Subchronic Toxicity

Chronic Toxicity

Carcinogenicity

Mutagenicity

Reproduction / Teratology Studies etc.

Median lethal dose (LD 50)

Reports Prepared More than 70 reports are prepared overall for CIS Countries, Russia, Latin

America, African countries, Middle East countries etc. Format And Guideline:- As per country

specific guideline.

Analytical Solutions

Analytical Solutions is a contract analytical laboratory that provides quality, timely and cost-efficient

analytical services to the pharmaceutical.

Our Strengths: Drafting of Analytical Data according to customer requirements & Rectify the query. Solve the

Validation query for Vietnam, Cambodia, Myanmar, Kenya, and Tanzania etc.

Product performance testing

(including dissolution, release rate and content uniformity) Release testing for Active Pharmaceutical Ingredients (APIs) and formulated drug products Process Validation, Analytical Validation, Stability

data studies, Analytical Report,

Impurity profiles, Related substances report _ Dissolution profile

Zenith Dossier Solution

Medical Writing Clinical Studies

We provide services of Medico Writing to Pharma Industry. The Medical Writing services cater to the regulatory aspect by searching

literature / Published studies / Journal Articles Or buying individual

published articles from different sources.

Service Provided Justification for fixed dose combination.

Prepare Periodic Safety Update report (PSUR). Prepare Summary of product (SPC), Pack Insert, Product rationale.

Expert Reports on - Quality, Pre-clinical, Clinical Overviews - Clinical / Non-Clinical (Module 2)

Nonclinical Study Reports (Module 4) Clinical Study Reports (Module 5) Reports prepared More than 1000 reports are prepared overall for CIS Countries, Russia, Latin America, African

countries, Middle East countries etc.

Countries

Zenith Regulatory Service has a rich experience of providing services across therapeutic segments

( including animal health and herbal products dossiers ) and has registered more than 2000 products in

over 50 countries for Pharmaceutical Industry worldwide.

Asia

Bangladesh Lebanon Saudi Arabia Bhutan Malaysia Combodia Cambodia Mongolia Srilanka Hongkong Myanmar Myanmar Indonesia Nepal Thailand Iran Paksitan Turkey Iraq Papuanew guinea Vietnam Laos Philippines Yemen

Africa

Algeria Kenya Senegal Botswana Madagascar Sierra leone Burkina Faso Malawi (Nyasaland) Sudan Cameroon Mali Tanzania Chad Mauritania Togo Congo Mauritius Tunisia Egypt Mozambique Uganda Ethiopia Namibia Zaire Gambia Niger Zambia Ghana Nigeria Zanzibar Ivory coast Zimbabwe

Central America

Costarica Guatemela Nicaragua Cuba Haiti Panama Dominican Republic Hondurus Trinidad Elsavador Jamaica

South America

Argentina Chile Guyana Bolivia Ecuador

North America

Mexico Suriname Venezuela Peru Uruguay

CIS countries

Azerbaijan Kazakhstan Turkmenistan Belarus Kyrgyzstan Ukraine Estonia Russia Uzbekistan Georgia Tajikistan

Contact

Zenith Regulatory Service Address: 43 P, Sec-9A Near ESIC Hospital Gurgoan-122001

Telephone+91-8950072720

Email:zenithadvantage@gmail.com