Regulatory Affairs & Marketing Authorizations
Your Virtual Regulatory Affairs Office in New Delhi, India
Regulatory Affairs Services in the Domains of:
Drugs & Cosmetics Act | Drugs & Magic Remedies (Objectionable Advertisements) Act | Food Safety & Standards Act
Drugs | BioPharmaceuticals | Medical Devices | Botanicals | Cosmetics | Nutraceuticals | Functional Foods | Dietary Supplements |
Medical Purpose Foods | Ayurvedic-Homeopathic-Unani Drugs
❱ ❱ Regulatory Reviews of Product Claims, Labels, Package Inserts, Advertisements, Marketing Material
❱ ❱ Regulatory Updates & Intelligence
❱ ❱ Registration Strategy
Regulatory Classifications of products at the intersection of Drug-Food, Drug-Cosmetic, Nutritional Supplement-Functional Food etc.
❱ Technical Dossier Writing
❱ Electronic Dossier Publication
❱ Maintaining Licenses and Technical Dossiers
❱ In-Country Representation
❱ Holding Marketing Authorizations
❱ Marketing Authorizations
❱ Regulatory Liaison
❱ Consumer Feedback Management
❱ Human Intervention Studies
❱ Outcome Studies
❱ Quality of Life Studies
❱ Training Sessions for Regulatory Affairs Executives, Marketing Teams
❱ GMP Audits & Training
Product Registrations in India & South Asia
We can facilitate your Business Plans for an emerging $35b Pharma Market!
Just the way we’ve navigated some of the global top 10 companies in pharmaceuticals (including biologicals), medical devices, cosmetics, nutraceuticals and botanicals.
Apothecaries has Managed 300+ Marketing Authorizations for Pharma MNCs.We can hold Your Marketing Authorizations as Custodians, while your products' rights/IP remain with you. Whenever you are ready, we’ll seamlessly transfer them to your local entity or to your preferred licensees.
Who We Are
Our Doctrine
We are Committed to the Philosophy of Excellence.
(Commitment: A pledge to do a specific act or a thing; the state of being bound emotionally or intellectually to a course of action. Philosophy: A system of motivating concepts or principles; the system of values by which one lives. Excellence: The state, quality of condition of excelling; superiority)
We are dedicated to meet our Client's needs.
(Client: One who gives us a chance to provide him our services)
We work as a Team with our business partners in a spirit of trust and cooperation.
(Teamwork: Cooperative effort by group members to achieve a common goal. Business partners: Those with whom we do business - our customers and suppliers)
We believe in open Communication.
(Communication: The exchange of thoughts, messages or information)
We live and work Ethically.
(Ethics: The accepted principles of right and wrong that govern the conduct of an individual in relationship with others)
Each individual in our organization is Important and Responsible.
(Importance: Having great value, significance or consequence Responsible: Dependable, accountable, in-charge)
We focus on Accountability for every assignment.
(Accountable: Answerable; capable of being explained)
Our People
Dr. Brijesh Regal MPharm, PhD
Chief Executive Officer
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35 years' experience of coordinating and organizing 200+ clinical trials, involving 25,000+ patients
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Former WHO consultant and co-founder of an independent research ethics committee
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Coordinated evolution & documentation of Indian clinical research regulations (Schedule Y)
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Conceptualized National Pharmacovigilance Program for India
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Organized & led 150+ workshops for WHO, World Bank, CDSCO and private organizations
Dr. Andrew Salzman MD
Head - Medical Affairs & Clinical Development
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20+ years of experience in biomedical drug discovery and development
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Harvard trained infectious disease specialist.
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Gained approval for 10 INDs & CTNs, including FDA FastTrack
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Founded & led one of the largest pediatric critical care programs in North America
Dr. Yaacov Guy DSc (Medical Sciences)
Director - Regulatory Affairs
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23+ years of Pharmaceutical industry experience
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Quality Systems Specialist
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Postdoctoral Fellow and Guest Researcher at NIH, Rockville, Maryland
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Bioavailability studies specialist
Kapil Arora BPharm
Head - Regulatory Affairs
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Extensive experience of managing Regulatory Affairs for clinical trials (small molecules, biopharmaceuticals, medical devices, cosmetics, nutraceuticals, food products), including safety management
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Leads Central Pharmacy Management & Logistics for Drugs & Bio-Specimens
Chinmay BTech
Vice President - Corporate Development
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Manages Corporate Development, Sponsor interface, Budget management, Logistics, Vendor management, and IT-enabled services
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Led the development and implementation of Apothecaries' Clinical Trial Management System (CTMS), web-based randomization system (IWRS), Lab Information Management System (LIMS), AE reporting system & SOP Delivery system
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Leads evolution of service portfolio and Client Relationship Management
Sameer Agarwal MPharm, MS, MBA
Licensing & Portfolio Management Specialist -
EU & Asia
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More than 30 years' pharmaceutical industry experience: managing strategy, portfolio, acquisitions, licensing, sales & marketing.
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Headed global pharma businesses in the US, China, EU, Russia & South America.
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Managed products (including biosimilars) across oncology, , pain management, anesthesia, anti-infectives, critical care.
Chitra Agarwal MPharm, MBA
Business Management & Social Outreach Specialist (EU & Asia)
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More than 30 years pharmaceutical industry experience: Managing business set-up, development, corporate affairs, M&A and regulatory affairs.
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An accomplished trainer and social outreach professional.
Dr. Aashima Punyani MBA
Head - Clinical Trial Projects
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GCP Monitoring Specialist
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Experienced in initiating, managing and monitoring clinical trial projects
Dr. Garry Southan Post Doctoral
Analytical Chemistry & PK Scientist
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In-depth knowledge and experience of Bio-analytics
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Worked with Nobel Laureate Sir John Vane
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Extensive experience with Phase II projects
Dr. M Chandra Sekhar PhD
Director - Human Capital Management & Corporate Affairs
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Change Management Leader, with exceptional experience in managing Human Capital.
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25+ years’ experience in world class TQM practices
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Lead Assessor of People Capability Maturity Model of Carnegie Mellon University USA Qualified Lead assessor for people capability maturity model.
Arun Malik MBA
Director - Quality Assurance
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Quality Management Systems Specialist
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Extensive experience of implementing Quality Management Systems to improve excellence and growth
Dr. Suneet Aurora MD
Consultant Clinician
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Consultant Clinician experienced in development of clinical trial protocols
Anil Gupta BPharm
Director - GMP Affairs
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Veteran cGMP professional with long & wide ranging experience in pharmaceutical formulation manufacturing
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Led US-FDA approved pharmaceutical manufacturing facility producing injections (dry & liquid), tablets, capsule (soft & hard), dry syrups, oral-liquids, ointments & creams
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Experienced in setting up of new GMP facilities
Dr. Canan A Agartan MD
Director - Pediatric Clinical Services
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Professor of Pediatric Surgery.
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Former Clinical and Research Fellow,
Albany Medical Center Department of Urology, Albany, NY, USA -
Pediatric ICU and ECMO Education, Sophia Children Hospital, Rotterdam, Holland
Our History
Established as a consulting services company in 1983 – Apothecaries became the first Indian contract clinical research organization in 1993.
Since then we’ve been involved in clinical trials across Phase I to IV, for therapeutic areas such as Infectious diseases (bacterial, viral and others), Oncology, Dermatology (and VD), Respiratory System (including Asthma, COPD), Cardiology (including CHF, MI, Dyslipidemia), Psychiatry, Genito-Urinary System, Endocrinology (including diabetes), Nervous System (including CNS, PNS, Stroke), Pediatrics, Gastro-Intestinal System, Gynaecology, Pain Management, Organ Transplantation, Vaccines, Orthopedics, Dentistry, Haematology, Surgery, and Medical Devices.
Apothecaries has also emerged as a major Indian regulatory consultancy organization for global blue-chip as well as for emerging pharma companies based at US, EU, Japan, Australia and India.