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.
Global Licensing Partnerships
Pharmaceuticals | BioPharmaceuticals | Medical Devices | Nutraceuticals | Food-safety | BioMarkers | Diagnostics
Apothecaries connects you with Partners for co-development and commercialization, enabling you to deliver innovative new products and technologies around the world through collaborative alliances that produce lasting benefits.
Through a well-structured and credible operational system for identifying right partners to help you develop or commercialize your intellectual property (IP), technology or product created by your organization. To help you optimize your mutual capabilities, expertise, and resources.
The In-licensing & Out-licensing opportunities we create Include end-to-end services:
Fair and Reliable Partner Identification
Designing Partnerships to Optimize Mutual Benefits
Product co-development, including Clinical Development
Providing Strategic inputs for situation specific contract R&D
Partnering for approved products
Managing dossiers for global applications based on the ICH Structured/US/EU/Japan dossiers
Pharmaceutical production partnerships, based on audits of manufacturing facilities
Market positioning and pricing strategy inputs
Market-specific labelling/packaging of products
Lifecycle management with marketing authorization maintenance and ongoing process improvement
Distribution & Logistics Partnerships
Clinical Trials/Human Intervention Studies
Setting up Your Territory Specific Corporate/Legal Entities
Bureaucratic Processes & Liaising
Apothecaries Services are Offered as All Inclusive Service Packages: No Surprises.
In-licensing can be efficiently leveraged as a financial tool by recording related transaction as ‘in-process research and development’. The expenditure is considered expenses on the profit and loss statement, typically creating large losses, and offsetting tax liabilities.
Reach Us! We would be delighted to explore synergy.
Send us a non-confidential description of how we may be able to work together.
Our Licensing Specialist will match your asset/project/requirement with our resources and capabilities and will initiate a dialogue with you with a firm proposition.
Apothecaries strives to create innovative value for your products, technologies and dreams.