This document provides an overview of services offered by Medwisdom Lifesciences Private Limited, an Indian regulatory consulting firm. The company assists clients with regulatory submissions for pharmaceuticals, herbal products, nutraceuticals, cosmetics, and medical devices to international regulatory authorities. Services include dossier preparation, responding to regulatory queries, product lifecycle management, pre-cGMP audits, regulatory intelligence, documentation writing, and auditing. The company aims to help small and medium pharmaceutical firms comply with regulations through technical and regulatory support.

1. MEDWISDOM LIFESCIENCES PRIVATE
LIMITED
INDIA
Phone: +91-9264127040
E-mail: reg.medwisdom@gmail.com
Website: www.medwisdom.in
Regulatory
service/
Technology
transfer
Medwisdom Lifesciences Private Limited
Your satisfaction is our goal
OVERVIEW OF SERVICE
MEDWISDOM, we assist you with a wide range of services that cover all the
stages of development and regulatory submission of PHARMACEUTICALS,
HERBALS, NUTRACEUTICALS, COSMETICS, MEDICAL DEVICES to meet
the requirements of regulatory authority of USA, EMEA, ASEAN, CIS,
MENA, LATAM, EAC and other countries specific requirements.
We prepare the initial submission dossiers as per CTD, ASEAN, EAC and
countries specific guideline. Response of the products queries to get the
product approval. Also we maintain the product lifecycle managements on
the behalf of clients.
We also assist and perform pre-cGMP/QMS audit to meets the cGMP
requirements as per ICH, 21 CFR, EMEA, PICS, ISO.

2. PRIVATE POLICY
We ensure privacy and confidentiality of the
client’s data. A non-disclosure agreement
(NDA)/ confidentiality agreement (CA)/
Confidential disclosure agreement (CDA)/
proprietary information agreement (PIA)/
Secrecy agreement (SA) will be signed by us
before starting or signing of any projects. As per
company policy/norms, Privacy and
confidentiality of data is our main objective.
MEDICAL DEVICES
Classification of medical device, preparation of
technical master file, Clinical and non-clical
expert report of medical device and in vitro
diagnostic.
Pre-QMS audit (ISO 13485)
Expert advice covering a wide range of products,
from simple bandages to the most sophisticated
life-supporting products, the medical devices
sector plays a crucial role in the diagnosis,
prevention, monitoring, and treatment of
diseases and the improvement of the quality of
life of people suffering from disabilities.
ABOUT US
MEDWISDOM is a Life sciences consultant.
We offer a wide range of services in the areas
of DEVELOPMENT, TECHNOLOGY
TRANSFER, REGULATORY AFFAIRS,
PATENT, CLINICAL and NON-CLINICAL,
MANUFACTURING, FACILITY AUDIT. We
consist of team of expertise person having
more than 15 years of experiences in the
consulting. We are dedicated mainly to the
QUALITY, TECHNICAL, REGULATORY AND
TRAINING CONSULTANCY to
PHARMACEUTICAL/DEVICE/FOOD
INDUSTRY. We aim at helping small to
medium size pharmaceutical companies in
complying with the regulatory norms by
providing and assisting them in their technical
Matters.
We are providing services like compilation of
regulatory files, DMF, Internal Audits, Pre-
audits, Preparation for Regulatory or any other
Audits, Professional training programs for skill
development and Personality development for
pharmaceutical staff and technical
Professionals. On site cGMP and Technical
Training is also our expertise and we believes
in concept clearance for smooth and Quality
Functioning of Pharmaceutical Industry.
MEDWISDOM is achieved a level of Excellence
in REGULATORY SUBMISSIONS and
compilation/review of Dossier, DMF for
Pharmaceutical Products registration and well
aware about CTD, eCTD, ACTD and other
national submission requirements. We are
capable of handling and answering all
TECHNICAL QUERIES of registration
authorities.
We are also providing the Quality assessment
and monitoring services to international
pharmaceuticals companies who are buying
medicines from Indian manufacturers.
We have expert auditors team with us who are
having more than 20 years individual
experiences for auditing pharmaceutical
companies.
REGULATORY INTELIGENCE
REGULATORY INTELLIGENCE: drug, device
and diagnostics development is an expensive,
time-consuming and complex undertaking.
Getting the regulatory strategy right, recognising
the potential pitfalls and understanding the
requirements for your specific product is of
utmost importance.
We analyse your particular projects and help you
to fully understand the regulatory environment,
taking into account precedents and current
regulatory thinking. In close co-operation with
your team, we develop the specific road maps that
apply to your projects.
We make a strategy in each stage of regulatory
activities (PRE-SUBMISSION, SUBMISSION,
ASSESSMENT AND POST SUBMISSION).
DOCUMENTATION
MEDWISDOM team has expertise in technical
writing, especially in the Chemistry
manufacturing control, Clinical and non clinical
expert report, Standard operating procedure
(SOP) for the research and development (RnD)
and Manufacturing facility.
We also provide the template for SOP writing
specially for the quality manual and other relevant
SOP for quality management system (ISO 9001
and ISO 13485).
AUDITING
MEDWISDOM is regularly involved in auditing or
issues related to GXP. We are called upon by clients to
conduct GMP inspections or provide technical/
documentation reviews with respect to GMP issues,
either as part of a larger strategic review or as due
diligence for selection of third party contractors. We
can offer the following services in this area:
GMP
MEDWISDOM contributes to the auditing process by
documentation review to ensure that product-specific
issues are addressed, such as requirements in shared
manufacturing facilities. Our expertise has also been
called upon during GMP inspections, either to aid in
the inspection process or to liase with the inspecting
authorities.
QMS
Perform pre-audit for QMS (ISO 9001 and ISO 13485)
PRODUCT DEVELOPMENT
During stages of early product development,
MEDWISDOM can offer useful advice on issues
of importance for future expedient approval. In
our specialised field of PHARMACEUTICALS,
BIOLOGICS, BIOTECH, COSMETICS, HERBAL,
MEDICAL DEVICE. We inform clients of
requirements for manufacturing and control,
emphasising the importance of the documenting
process as well as product consistency. We have
expertise in the design of assays, and can develop
statistical models for their evaluation according
to pharmacopoeial requirements. Review of
production processes and facilities and design of
validation protocols are also within our
capabilities. In addition, we can produce
qualified input for the planning of appropriate
stability studies, non-clinical studies and clinical
trials.