2. Overview
Key Persons
Credentials
Service Portfolio
Formulation Development Division
Analytical Services Division
Bioequivalence Division
Archival
Quality Assurance
Data Integrity
Continuity Plan
Discussion
3. 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.
4. 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
5. 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.
8. 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
9. 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
10.
11. Facility:
A fully cGMP compliant 5000 sq. ft. state-
of-the-art Analytical Research facility.
It is well equipped with many
sophisticated analytical instruments like
MALVERN particle size analyzer,
Symphatec particle size analyzer, GC,
HPLC with various detectors like UV-VIS,
Fluorescence, refractive index, PDA
detectors, ICP-OES, Andersen Cascade
impactor 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.
12. 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
13.
14. 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.
15. 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
16. Facility
Spread over 6000 sq. ft.
space
Wet lab with multiple
processing counters
Dark room for light-
sensitive molecules
2 LC/MS-MS for handling
different assays
5 deep freezers with range
of -200C to -800C
Equipment's and software's,
21 CFR part 11 compliant
Micro-balance room
Chemical storage room
17. 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.
18. An archival section at ENEM
facilitates reconstruction of
projects as per regulatory
requirement.
In House archival facility at
both site
19. 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
20. ‘Data integrity’ is one of our strength.
Defined in our Quality policy as,
‘Nurturing a Culture of Honesty and integrity in all our activities
to 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
21. 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.
