Afra presentation (profile)

Presented
By

Mir Sadat Ali

www.afrapharmaconsult.org

COMPANY DESCRIPTION
 Afra Pharma Consultant (APC) is a private limited company based in
Pune, India, established in the year 2011, and is the leading provider of
quality resource for the regulation of pharmaceutical products including
those deemed as consumer Health and OTC.
 The services are designed to meet all of the latest regulations, helping
clients to meet all of the stringent requirements of the pharmaceutical
world.
 Afra Pharma Consultants has a satisfied network of clients, situated
throughout the Europe, Asian countries, North Africa, GCC, Saudi
Arabia and India.
 Afra Pharma Consultant strives to develop long-term relationships with
clients, based on the highest levels of integrity, professionalism and
trust.
 We are committed to doing business in an ethical and socially
responsible manner.

“EXPANDING CONSULTANCY BEYOUND
EXCELLENCE”


Our Goal:
is to enable you to achieve your goal
and to be the first choice of our clients
in all their needs and services we
offer.


Our Mission:
is to Excel
Exceed customer
Expectations
by delivering the commitments
we make.


Our Vision:
being recognized as successful
provider of superior quality and
cost effective services to the
Pharmaceutical Industry
worldwide.


OUR SERVICES
The services are designed to meet all of the latest
regulations, helping clients to meet all of the stringent
requirements of the pharmaceutical world:

 REGULATORY
 CLINICAL RESEARCH
 PHARMACEUTICAL ENGINEERING
 TRAINING
 PIL
 PROJECT MANAGEMENT
 AUDITS AND INSPECTIONS
 STRATEGIC PLANNING

OUR EXPERTISE
Several companies die due to inability to deal with changing
regulatory requirements in a specific region. Our objective is to
provide customize solution to any such problems through the
highly talented and experienced group of consultants from
Middle East.
Middle East and North Africa is our strength and we can cater
all your requirements in this region such as:
 Identifying potential collaborators for joint venture projects
in the GCC.
 Identifying potential acquisition/joint venture/ partnerships
in the GCC Market place.
 Mock cGMP Audit
 Technology, Acquisition and Transfer.

OUR EXPERTISE
 Identification and evaluation of Contract Manufacturing
Services.
 Sourcing of Pharmaceutical equipment and raw materials.
 Designing state-of the art manufacturing facilities
 Revamping and upgrading existing manufacturing plants
 Helping in identifying & refining Strategic Business
Direction.
 Production Rationalization
 Preparing dossiers and drug registration with the Saudi FDA,
GCC.
 Training for cGMP and all regulatory related topics.


REGULATORY

 Our strength is a team of consultants with experiences
ranging from 10-15 years in regulatory services in
regulated and non regulated markets, competence in
Human medicines, Veterinary medicines, medical
devices, Herbal drug and Dietary supplements.
 Our Commitment is total confidentiality, time bound
submissions and providing regulatory support till the
product is registered and marketed.


REGULATORY

Dossier compilation as per:
 ASEANCommon Technical Dossier (ACTD)
Guidelines.
 South Africa (MCC-MRF-1) Guidelines
 Brazil ANVISA Guidelines.
Dossiers compilation for submissions in:
 Asia
 Africa
 Central America
 South America
 North America


REGULATORY
Dossier compilation in Common Technical Dossier (CTD) format for
 Commonwealth of Independent States (CIS) Guidelines.
 South East / West Europe Guidelines.

Drug master file (DMF) compilation for open and closed parts
Prepare Summary of product (SPC), Pack Insert, Product rationale.

Expert Reports
 Quality,
 Pre-clinical,
 Clinical
Nonclinical Study Reports (Module 4)
Clinical Study Reports (Module 5)
Dossier conversion (from one country to another)

PRE AUDIT
Afra Pharma Consultant assists clients to prepare for an imminent
regulatory inspection by carrying out one or more mock regulatory
audits in advance of the real thing.
Our consultants will visit your facility and carry out an inspection in
the style of the relevant regulatory body (FDA, MHRA, EMA, Saudi
FDA, GCC etc.) after which we provide:
 An in-depth, impartial and professional assessment of their current
state of compliance
 A detailed, prioritized action plan for the rectification of areas of
non-compliance and vulnerability
 Staff coaching in the sorts of questions which are likely to be
asked during the inspection and how best to answer them
 Sound, practical support and advice in the run-up to the real
inspection.

CLINICAL RESEARCH ORGANIZATION
Afra Pharma consultant offer to conduct, manage and monitor multicentre
Clinical Trials in a wide range of therapeutic areas and monitor BE studies in
India and abroad. We have a special interest in Independent Clinical Trial
Monitoring Work in India and abroad for sponsors from India and abroad.
Medical Writing & Clinical Studies.
 Bioavailability.
 Bioequivalence.
 Clinical Trial Studies.
 Analytical Solutions
Reports on
 Bioavailability / Bioequivalance Studies,
 Clinical Trials studies
 Prepare Periodic Safety Update report (PSUR).
 Preclinical studies like Toxicity, Carcinogenicity, and Teratology &
Reproduction toxicity.

PHARMACEUTICAL ENGINEERING

Afra Pharma Consultant has collaboration with an ISO
90001 certified worldwide Pharmaconsulting and
engineering company with more than 1600 people at
more than 20 locations worldwide and handles up-
gradation projects to turn key projects in
Pharmaceuticals, Biopharmaceuticals, Medical
devices, vaccines and industrial biotech.


TRAINING

Afra Pharma consultant has collaboration with leading trainers
with 10-15 years industrial experiences and have conducted
number of training sessions in Topics related to Regulatory,
clinical research and cGMP.
We can conduct several training programs and interactive
workshops on regulatory support periodically. The nature and
course content is tailored to suit specific managerial levels in
the organization.
APC also undertakes to develop and conduct courses with
specific focus when specially requested by customers. These
courses can be conducted at either in-house or a private
meeting room.

WHY APC
 Experienced, Professional, Focused practice and easy to
work with.
 We specialize in preparing and handling regulatory
submissions for Saudi FDA and GCC.
 For mock Audit as per MHRA, SFDA and GCC.
 Reach out to Global Market.
 To have timely and faster dossier preparations and
submissions.
 For one stop requirements for all your regulatory needs.
 Offer concept to commissioning (turn key projects) of
pharmaceutical and CRO facilities.
 Wide network of consultants across India, U.K, U.S.A,
Middle East to South Asian Countries.

H/201 Hillmist Harmony,NIBM Road, Pune 48.
Email: info@afrapharmaconsultant.org


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