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
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)
Established as a pharmaceutical consulting services company in 1983 – Apothecaries has been providing contract clinical research services since 1993.
We have been involved in clinical trials across Phase I to IV, for therapeutic areas such as Infectious diseases (bacterial, viral and others), Oncology, Burns, Wounds, 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 also offers regulatory consultancy services for global blue-chip as well as for emerging pharma companies based at US, EU, Japan, Australia and India.