Unique combination for all your requirements

Overview Key Persons Credentials Service Portfolio

Formulation Development Division Analytical Services Division Bioequivalence Division

Archival Quality Assurance Data Integrity Continuity Plan Discussion

Enem Nostrum Remedies Pvt. Ltd. is one of the India’s leading Pharmaceutical Research Centre providing full fledge services like Formulation Development, Analytical Services and Bioequivalence studies.

Operational since last 15 years Spread over 50,000 sq. ft. (Two facilities) Trained and experience researcher to provide unique

solution to our valuable clients Experienced in handing First to File projects.

Name Department Qualification

Dr. Rajiv Merchant ENEM Nostrum Ph.D.

Ms. Veena / Mr. Anish Shaikh

Formulation Development

M.Sc.

Mr. Tushar Gaikar Analytical Research M.Sc.

Dr. Harishkumar Lalan Clinical MBBS, MD

Dr. Sanjay Vaze Clinical MBBS

Ms. Archana Shetye Bioanalytical M.Sc.

Mr. Santosh Mohite CQA M.Sc.

Mr. Sameer Shelar QA- Govandi M.Sc.

Mr. Amit Khandagale BD & PM M.Sc, EPBM

Facility Inspection USFDA – Andheri Unit

Facility Approval ISO 9008-2015 – Andheri Unit DCGI – Govandi Unit

All assignments taken by us is as per our own SOPs and all are comply to National and International regulatory authorities.

Enem

Nos

trumFormulation Development

Analytical Services

Bioequivalence

Facility: 3000 sq. ft. formulation development facility

located just 10 minutes drive from Airport Can handle controlled substances. V Blenders with intensifier bar (Patterson Kelly)

for precise blending, uniformity and efficiency. Roller Compactor for dry granulation High Shear Granulator for wet granulation High speed tablet press with force feeder

(SEJONG) and Bilayer tablet press Autocoater for coating for tablets SCADA Controlled Fluid Bed Coater / Granulator

based on GLATT technology capable of handling 1-5 kg material at a time.

Extruder and Spheronizer for formulation of pellets

Buchi Spray dryer/ congealer Stability cabinets to evaluate product stability

based on real-time, accelerated and long-term protocols by controlling temperature and relative humidity

Expertise:Characterization of innovator products for ANDA

development Standard protocol for all development studies Encapsulation of drug/excipient for toxicity studies Development of NDA and ANDA products Excipient compatibility studies

Facility: A fully cGMP compliant 5000 sq. ft. state-

of-the-art Analytical Research facility. It is well equipped with many

sophisticated analytical instruments likeMALVERN particle size analyzer,Symphatec particle size analyzer, GC,HPLC with various detectors like UV-VIS,Fluorescence, refractive index, PDAdetectors, ICP-OES, Andersen Cascadeimpactor for MDI and DPI products etc.

3000 L Capacity Stability chambers as per ICH.

Analytical data management systems, meeting to the needs of 21CFR Part 11 compliance.

Inspected and approved by USFDA.

Expertise: Analysis of Active and Inactive pharmaceutical ingredients, chemical

intermediates and finished products Method Developments & Validation of analytical method for assay of

active ingredients, impurity profiling, residual solvents, Particle Size, etc. Force degradation studies Analysis of elemental impurities and assay using ICP OES Characterizations of Molecule using UV and LC-MS Analysis of MDI and DPI using Andersen Cascade impactor, Glass

Impinger and DUSA Dissolution development studies

Facility Spacious clinical ward with an area of

about 10,000 sq. ft. One fully equipped 2 beds ICU State-of-the-art two identical clinical wards

of 36 beds each comprise total beds to 72. Proximity to a hospital that will facilitate

quicker and better handling of emergencies Pharmacy with controlled access. Counseling room with audio-video

recording facility Emergency calling point at bed and in wash

room A recreational facility for subjects during

the study Dedicated nurse/lab technician for samples

withdrawal and care Volunteers’ data bank of 1,000 + volunteers - 800C deep freezers for plasma sample

storage which are continuously monitored through data logging system.

Expertise Can Conduct the studies in different Therapeutic area like, lipid-

lowering agents, anti-diabetics, antidepressants, Antibiotics, NSAID's, antiepileptic, muscle relaxant, cardiac drugs etc.

Experienced in conduction of ‘Onco’ Products on healthy volunteers Studies perform on different formulations like, Tablet, Capsules,

Syrups, Suspension, IV, Sprays etc. Can handle male and female volunteers study separately Lead time to finalization of documents is very less Submission of all reports in eCTD formats

Facility

Spread over 6000 sq. ft.space

Wet lab with multipleprocessing counters

Dark room for light-sensitive molecules

2 LC/MS-MS for handlingdifferent assays

5 deep freezers with rangeof -200C to -800C

Equipment's and software's,21 CFR part 11 compliant

Micro-balance room Chemical storage room

Expertise Level of detection 0.5ng/mL Can quantify up to 0.1ng/mL Capacity to analyze about 10000 subject samples/month considering

existing capacity Proficiency in different molecules like endogenous molecule and

low sensitive molecules Apprx. Developed about 1-2 methods every month. Separate team for method development and validation Can handle all type of molecules of various chemical property Till date developed over 30 methods in short period of time.

An archival section at ENEMfacilitates reconstruction ofprojects as per regulatoryrequirement.

In House archival facility atboth site

Implementation and maintaining system in compliance with ‘GxP’.

Training on ‘Gxp’ on regular intervals. In process and retrospective periodic internal

audits. Continual Improvements through CAPA Document control, record management &

archiving

‘Data integrity’ is one of our strength. Defined in our Quality policy as,

‘Nurturing a Culture of Honesty and integrity in all our activitiesto provide quality services”.

Imbibed in every employee of Enem at the time of Joining. Periodic trainings on course of ‘Data integrity’ with different

case studies in discussion. Access controls are well defined through out the organisation,◦ Different areas, locations ◦ On various instruments and equipments ◦ Archrivals ◦ Servers

Leadership and Staff Continuity Attrition rate is less than 5% for higher management and 10% for staff Strong second line development strategy. Robust recruitment and training procedure.

Operational Continuity Owned facility Over 160 staff (including contractual) for conduction of any project Comply to all regulatory requirements Remote location data storage

Vendor and Customer Continuity Robust vendor approval process Believe on Customer satisfaction

Business Continuity Procurement of new LC/MS-MS instruments by Q3 FY 16-17. Increasing stability chamber capacity from 10,000 Ltrs to 20,000 Ltrs. Recruiting 30+ more professional to carry our BA/BE projects.