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 Research
Your Own Virtual Clinical Trial Project Management Office
Apothecaries performs as a transparent extension of your own organization.
CTPT (Clinical Trial Patient Tracker) - Our Proprietary Software gives you 24x7 online access to project matrices so that you never feel out of touch with the project progress.
You also receive a succinct, well-structured weekly project report in your mailbox every Monday morning. Feel free to pick up the phone and talk to anyone in your study-dedicated team anytime you like.
Apothecaries has well established systems to initiate tens of sites in a matter of weeks, achieving FPI in under 12 weeks in many cases.
Send us an RFP and we’ll provide you a TechnoCommercial Offer outlining how our team will manage -
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Study conceptualization in line with your specific objectives
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Development & production of study documents including Protocols & CRFs
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Regulatory affairs
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Study planning & organization
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Engaging Labs, Sites & Investigators
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Investigators' meetings, project staff trainings
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Managing enrollments at an outstanding rate
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Placement, tracking and payment handling
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Central pharmacy services and logistics activities
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Study hotlines, phone monitoring services
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Quality checks and tracking of completed CRFs
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AE/SAE, ADR/SADR information management
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Quality assurance & quality control, including monitoring & audit services
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Logical & medical review of CRFs
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Data management including data entry for paper CRFs, Query management
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Biostatistics, generation of study reports
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Ongoing review and change management
Observational Studies
Apothecaries can plan and execute your
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Observational Studies
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Patient Registries
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Epidemiological Studies
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Drug use and treatment outcomes in real-world clinical practice, and
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Post-Approval Safety-Surveillance Studies
In-Home Clinical Trials
Taking Clinical Trials to Patients' Homes for Better Enrolment, Compliance & Retention.
Based on Study Protocols and patients' condition - our SMO service can deploy trained and licensed service providers (nurses, technicians, clinicians) to organize home (or workplace) visits for:
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Study drug administration
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Taking biological specimens (e.g. blood samples for PK, safety tests etc.) swabs, urine etc.
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Clinical assessments e.g. vital signs (BT-BP-HR-RR), ECG etc.
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Patient compliance checks, training, counselling and education
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Patient diary completion etc.
Providing Home Visit option goes a long way in enhancing patient recruitments, compliance as well as retention.
Repurposing Studies
ClinicalTug™ - our end-to-end project management service can facilitate a well-informed Yes-No decision about your Repurposed drug concepts by organizing very swift and economical Proof-of-Concept clinical trials.
Patient enrolments can be initiated within weeks after the project is assigned to Apothecaries.
This can take you much closer to your next round of funding. Or to an adequately powered clinical trial.
In fact we can also arrange funding for your Repurposed Drugs’ PoC clinical trials.
Botanical Trials
Apothecaries has an exceptional understanding of Botanical Drugs and FDA's requirements for registration of Botanicals as therapeutic agents. We've managed several small Proof-of-Concept as well as large clinical trials on Botanicals and Phytochemicals in therapeutic areas as diverse as Immuno-Oncology, Pain, Dermatology, Gynecology, Pediatrics, Hepatology, CVS etc.
Our CMO partners, specializing in Botanicals, can manufacture small batches of formulations under GMP conditions.
Apothecaries can start clinical trials on your Botanical products in exceptionally short timelines.
Nutraceutical & Cosmeceutical Trials
Apothecaries has managed tens of studies for generating Evidence Base for Credible Marketing & for Regulatory Compliance related to Food products, Nutritional Supplements, Phytochemicals & Nutraceuticals.
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Long term safety and tolerability studies
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Epidemiological studies
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Quality of Life studies
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User reported outcomes, based on analog scales
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Investigator reported outcomes based on measurable end-points & surrogate end-points
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Long term safety and tolerability studies
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Inhalation safety & tolerability studies
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Topical safety & tolerability studies
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Epidemiological studies
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Photography in calibrated, standardized conditions
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User reported outcomes, based on analog scales
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Investigator reported outcomes based on measurable end-points & surrogate end-points
Patient Enrollments
Apothecaries has recruited tens of thousands of patients for clinical trials in:
Oncology | Gynecology | Tuberculosis | Pain Management | Dermatology (and VD) | Organ Transplant | Respiratory System (including Asthma, COPD) | Vaccines | Cardiology (including CHF, MI, Dyslipidemia) | Orthopedics | Psychiatry | Dentistry | Genito-Urinary System | Hematology | Endocrinology (including Diabetes) | Surgery | Nervous System (including CNS, PNS, Stroke) | Medical Devices | Pediatrics & Geriatrics | Infectious Diseases | Gastro-Intestinal System (bacterial, viral & others) | Topical and Inhalation Safety & Tolerability Studies
Here's a preview of how many patients we can possibly enroll* in one year:
5000 Asthma
25000 Diabetes
200 Rheumatoid Arthritis
500 Migraine
1000 Herpes Zoster
5000 Cataract
5000 Glaucoma
100 K Postmenopausal Women
1000 Vaginal Atrophy
500 Infertility
100 K Anemias
100 K Dialysis
100 K Malnutrition
1000 Dementia
250 Alzheimer’s
200 Parkinson’s
200 K Male Pattern Alopecia
1000 Hypercholesteremia
500 K Healthy Adult Vaccinations
300 Adult Urinary Incontinences
150 Multiple Myeloma
1000 Breast Cancer
200 Prostate Cancer
200 Myeloid Leukemia
200 Endometrium Cancer
150 Non-Hodgkin’s Lymphoma
100 K Alcohol Addiction
100 Bone Marrow Transplants
5000 Psoriasis
100 K Hypertensives
1000 Hypertriglyceremia
10000 Pediatric Vaccinations
2000 Tinea Pedis
100 K Angioplasties
500 Endometrial Benign Fibroids
2000 Cancer Pain
50 Pancreatic Cancer
500 Lung Cancer
200 Gastric Cancer
100 Bladder Cancer
3000 Head & Neck Cancer
100 Acute Lymphoid Leukemia
700 Ovarian Cancer
50 Renal Cancer
100 Glioblastoma Patients
400 Hepatic Carcinoma
50 Thyroid Cancer
We'll be glad to study your specific requirements and provide you customized solutions for swift & compliant patient enrolments.
Send us your RFP for a TechnoCommercial proposal.
*These numbers provide an estimate of the number of patients we can access for enrolments. Actual enrolments will of course depend upon your protocol’s specific inclusion-exclusion criteria.
Proof of Concept Trials
ClinicalTug™ - our end-to-end project management service can facilitate a well-informed Yes-No decision about your concepts by organizing very swift and economical Proof-of-Concept clinical trials.
This can take you much closer to your next round of funding.
Or to an adequately powered clinical trial.
Our therapeutic experiences include Oncology, Gynecology, Pain Management, Dermatology & VD, Respiratory System (including Asthma, COPD), Cardiology (including CHF, MI, Dyslipidemia), Orthopedics, CNS, Psychiatry, Dentistry, Genito-Urinary System, Hematology, Endocrinology, Surgery (including wound healing), Organ Transplant, Infectious Diseases, Vaccines, Pediatrics and Geriatrics.
Order a Risk Free Trial:
Apothecaries Underwrites Compliance.
Compliance with Regulations. Compliance with Timelines. Compliance with Budgets.
Pediatric Trials
Right from Neonates to Teenagers - we've the experience of managing pediatric clinical trials involving vaccines, hormones and dermatology products.
We deeply understand the sensitivities, unique challenges, nuances, enhanced scrutiny and the emotive issues and have been managing them very skillfully. And successfully.
Medical Device Trials
Planning and execution of complete clinical investigations to assess performance and safety of all classes of medical devices.
Cardiovascular devices | CNS devices | Dental devices | Dermatology devices | Endocrinology devices | Gastroenterology devices | Immunology devices | Musculoskeletal devices | Nephrology devices | Ophthalmology devices | Pulmonary devices | Surgical devices | Oncology devices | Implantable devices including drug-coated or drug-eluting stents and device-based drug delivery systems
Safety Surveillance Studies. Observational Studies. Patient Registries.
End to End Project Management.
Compliance with ISO 14155
ClinicalTug™ Clinical Co-Development Service
Swift. Frugal. Compliant.
Our ClinicalTug™ Risk Sharing Co-Development provides you:
❱ Operational support as well as capital: Shared risks & rewards with amazing cost efficiency. Backed by Apothecaries’ 25 years clinical development experience.
❱❱ Off-balance sheet financing: Linked with pre-negotiated project performance and sophisticated, milestone based short-term/deferred reward sharing.
❱ De-risked project execution: ClinicalTug™ underwrites compliance with regulations, timelines & budget.
❱ Amazingly cost efficient: A completely new Cost:Time paradigm.
❱❱ All inclusive, shared project budget: Absolutely zero pass-through costs. No surprises.
❱❱ ClinicalTug™ can also facilitate patient enrollments for your clinical trials much sooner than your original plans, at substantially lower costs. Very Swift Start-up. Initiating Tens of Sites in a matter of weeks.
❱❱ Highly experienced drug development professionals: Collaborating to augment your team for creating optimal clinical development pathway and providing operational oversight. Covering all aspects of clinical development: Protocol design to Operational strategy, including recruitment plans, monitoring, data management platform and process, statistical analysis, CSR preparation and regulatory affairs.
❱ Meeting or exceeding project performance parameters: we succeed only when you do.
❱ Proof of Concept studies for swift Yes-No decisions for further development, empowering you with objective opportunity assessment
❱ Faster & more assured presentation to Big Pharma for out-licensing or investors for next round of financing.
❱ Vaccine Studies
❱ Observational Studies, Outcome Studies, Epidemiological Studies
❱ Rescue Studies.
❱ Across therapeutic areas.
❱ For Small Molecules. Biologicals. Medical Devices. Diagnostics. Botanicals. Cosmeceuticals. Nutraceuticals.
Interested in Co-development?
Let's discuss how we can amazingly change the trajectory of your clinical development plan.