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.
Clinical Co-Development Investments
We're looking forward to invest in bright ideas in life sciences,
including Pharmaceuticals, BioPharmaceuticals, Medical Devices, Botanicals, Nutraceuticals & Cosmeceuticals.
Orphan Drugs & 505(b)(2)s particularly excite us.
There's much more than capital that we bring on the table!
Apothecaries offers access to a wide and well-nurtured network of life-sciences professionals
across US, Europe, Middle East, India & South East Asia.
With a team which has more than a century's cumulative experience, our deep & sophisticated understanding
of the drug development & regulatory affairs enables us to clearly understand your requirements
and to provide meaningful solutions.
Our investment philosophy is to partner with management teams to promote & advance mutual joy!
We strive to invest in areas where our industry knowledge, network and experience will add immense value.
Let's discuss your plans if you are on the threshold of starting Phase II or Phase III clinical trials,
or are ready to market your products.
We are particularly keen on ventures engaged in clinical development & commercialization of
Nutraceuticals & Cosmeceuticals.
During the course of our partnership as investors,
We'll provide mentoring on various complex business situations, regulatory issues and market-access support,
particularly in India, South America, South East Asia, Middle-East and Far-East.
We have a unique and comprehensive understanding of the uncertain pathway that life sciences companies must travel in their pursuit of success. Our in-depth knowledge of the drug development processes enables us to provide insightful guidance and craft effective clinical and regulatory strategies.
We also endeavor to further the life of companies by leveraging our extensive professional network.
We take up an active role in supporting our portfolio companies, by nurturing partnership-style relationships
based on mutual respect, integrity, and a strong belief in the power of collaboration.
Apothecaries funds up to ~40% amount required for late stage clinical development.
How to Begin & What Happens Next
1. Check out our Initial Criteria
1. Your company has a focus on Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Nutraceuticals or Cosmeceuticals and you are at Phase II, III or IV of clinical development, or ready to commercialize.
We are particularly excited about Botanicals & 505(b)(2) candidates.
2. Your management team has domain expertise.
3. You are willing to partner with us for conducting clinical trials or licensing services, for which we will provide part funding.
4. You have an exit strategy proposal for us.
2. Write us an EMail
Tell us everything you would like to share to bring us up on your ideas in an initial email. Do include an executive summary & investor presentation.
Be as succinct & explicit as possible.
Our techno-commercial evaluation process would obviously need information about your product, team, operations strategy, financial projections & exit strategy.
Our team will perhaps ask you for some additional information.
If your idea excites us - we'll schedule a Phone Call or Video Conference.
4. Phone or Video Conference
We'll have an initial discussion to further understand your business idea, get to know each other better and explore how to get to the next steps.
You could take this opportunity to present your overall vision, financials, IP, corporate road map and fund raising goals.
We would suggest that you include your entire core team for this session.
5. We'll Meet
A lot of distance gets traveled when we are actually together in a room!
6. Due Diligence & Finalization
If everything looks good to both parties - we'd proceed with the paperwork and embark upon our journey with you.