Enhancing Business Value
We catalyse business growth by:
- Expanding International Business Network
- Enhancing Global Quality & Regulatory competence
- Multiplying profits from Indian Outsourcing & Market Access.
International Business Expansion
We undertake end-to-end services for expanding business internationally including Commercial Business Development, Quality Approvals of Facilities and Product Registrations / Marketing Authorizations.
Profiting from India
We help your Maximize Profits from India - be it from Outsourcing products or services, forging high-value Strategic Alliances / Acquisitions or Opening up huge Indian Market for your offerings with the most apt partners and channels.
GLOBAL Business Development
Using our > 25 years global building business experience, our core focus is evolving synergies with the right mindset international partners for driving sustainable growth. With our deep domain knowledge and insights, we deliver multiple avenues of growth from new countries / new partners and new products.
Help grow Geographically with strong best-fit Alliance Partners for Licensing-out / distribution of Products / Technologies in new countries or regions:
- HIGHLY REGULATED Territories in US, EU, Canada, AU/NZ, BR, ZA
- HIGH GROWTH EMERGING Territories in SE Asia, Middle East, Africa, Latin America
- INDIA - Unlocking a huge high potential market
For incremental revenues, we help you get access to New Differentiated Products (in-licensing, Technology Transfer or Distribution rights) in your portfolio:
- Speciality Rx Products [Oncology, Hormones, Ophthalmics, Respiratory MDI/DPI, Liposomal, Niche Injectables, MABs, NIBs, Suppositories], Orphan Drugs, 505 (b) (2) and Para IV filings
- Differentiated OTC or Food Supplements
- Differentiated Medical Device
India | Outsourcing for Competetive Edge
We help derive maximum advantage from India's global edge and prominence in Pharmaceuticals, Medical Devices and Healthcare by facilitating strategic growth partnerships. Our niche knowledge of highly competent 'hidden gems' and relationships with key stakeholders translates into a big difference in outcomes.
Efficiently Build and Manage Outsourcing Alliances
We deeply understand India, local industry, its corporate culture and have accumulated knowhow of highly competent ‘hidden gem’ companies operating below the line of sight and routine radars. With our deep domain knowledge, trusted network and insights, we help forge alliances with the most promising right-mindset business partners for CMO/CDMO/CRO or standalone services.
We have garnered extensive ground level experience being integral part of large global Indian companies and successfully delivered numerous projects working with diverse global / western companies of varied sizes, geographical origin & focus which sharpened our understanding of each side’s mindset and expectations. This unique dual-side (Indian and Western) experience allows us to successfully bridge the gap and tweak alignment between Indian deliverables and western expectations. This unleashes truly profitable business value and avoids expensive pitfalls that can render projects non-competitive or unviable (seriously affecting timeliness, quality and costs) and difficult to correct.
Significant Outcomes Improvement with Local Presence:
We undertake deep assessment and gather pertinent information for identification of issues and suggest most pragmatic and impactful solutions facilitating informed decision making and ensuring effective implementation.
- As your local eyes and ears, we provide deep insights and information on-ground competition, pricing, technical issues and supply chain issues. distribution channels etc.
- Streamline operations by resolving bottlenecks in Development, Manufacturing, Supply Chain etc.
- Seeking opportunities for enhancing revenues and profitability by finding new profitable partnerships and improved COGs
- Diversifying in new products or value-added services most helpful for gaining momentum
- Rapidly reducing supply risk by finding best-fit alternate / 2nd / 3rd source of API / FDF
- Sourcing of API’s, Formulations and Intermediates from India
- Identification & selection of Supplier / Partner for CMO, CDMO, offshore R&D Lab for CRAMS, Clinical Trials etc.
- Evaluate suppliers based consistency, efficiency, economy and extensive audits of quality systems / GMP compliance
- In-Licensing / getting Distribution or Marketing rights of Products in International Markets
- Audit of dossiers for completeness and compliance with requisite regulations
- Project Management for setting up Greenfield/Brownfield Facility
Segment-wise value added activities:
- Contract Manufacturing [CMO] / Site Transfer | FDF & API change
- Licensing-In and Technology Transfer
- Speciality Rx Products / Orphan Drugs / 505 (b) (2) and Para IV filings [Oncology, Hormones, Ophthalmics, Respiratory MDI/DPI, Liposomal, Niche Injectables, MABs, NIBs, Suppositories, PFS]
- Differentiated OTC, OTX, Herbal or Food Supplements
- Differentiated Medical Device & DIagnostics
- API Sourcing
- Development of alternate API Sources
- Contract R&D [CDMO] for API Development / Stability Studies / Analytical Development
- Regulatory Support [DMF / Site Master Files]
- End-to-End Project Tracking: From R&D / Development to Registration until Commercial Supplies
Managing, De-bottlenecking and Optimising Vendor deliveries to ensure better performance metrics (KPIs):
- On-Time Deliveries (OTD)
- Client-Service Levels (CSLM)
- Optimisation of Logistics Cost
For your existing or potential Vendor or Supplier of Finished Dosages or API, we undertake Third Party Audits in India, Asian Countries & Japan for:
- Manufacturing Site
- Clinical Facility
- Registration Dossier
- Contract R&D [CDMO] for full scale Development or standalone services for Stability Studies / Analytical etc. Development
- Clinical Research [CRO] & Bioequivalence Studies
- Regulatory Support [Dossiers / Expert Reports / Pharmacovigilance]
- End-to-End Project Tracking: R&D / Development, Registration till Launch
Flexible Options to establish Indian Presence:
ESTABLISHING 'VIRTUAL' INDIAN OFFICE
Get the advantage of your own presence by establishing 'VIRTUAL' Plug-N-Play Indian office without spending significant time and capital resources on creating legal entity. Quick start Indian outsourcing affairs in just weeks avoiding unnecessary hassles and initial business setup costs. Operations managed by highly experienced industry professionals who understand not only the pharma regulatory aspects, but are well versed with local business culture, operational realities, nuances and industry insights to ensure better supplier relationships. Manage your day-to-day operations with your suppliers / business partners for delivering better returns in both time and investment terms.
- Plug-and-Play operations fully aligned and in-sync with your corporate team and running seamlessly as per your corporate guidelines
- Highly experienced and qualified industry professionals managing agreed scope of operations ranging from Purchase to Supply Chain, Regulatory Filings to Artworks or Project Management, Product Development Projects, Third Party Audits etc.
- No need to bother about Payroll, HR, Expenses, Travel Management etc.
- Quick, Hassle free and Cost effective & with Lowest Exposure to risk
- Huge savings on Time & management Resources with no fixed investments or setup costs
- Fully equipped manpower with laptop / computer stations, printers & mobile / telephones, power backup and high-speed internet with video conferencing facilities etc.
- Bypass red tape / formalities of establishing legal entity by avoiding the hassles of office setup
ESTABLISHING 'FULLY MANAGED' INDIAN REPRESENTATIVE OFFSHORE OFFICE
Get your own Local Entity with Managed Indian Office, without spending time running from pillar to post to establish everything from ground zero. You get complete administrative backend support not just for establishing your local entity but also managing a fully functional office, seamlessly integrated & operational as per your corporate guidelines. This allows you to completely focus on key activity of driving sales and developing your business.
Setting up an India office with licenses, compliances, manpower, workstations and connectivity
Choosing right from Office Location to Company Incorporation, obtaining requisite Registrations and Approvals from Regulatory Bodies like RBI, Drugs Controller of India, DCI/CDSCO) for Drugs / Medical Devices, Goods & Service Tax (GST) Number, Income Tax (TAN/PAN) Number, Local Municipal Approvals, Import-Export Code (IEC Number) etc.
Offshore Manpower (fully aligned and operating seamlessly with your corporate team as per your corporate guidelines) for managing activities from Purchase to Supply Chain, Regulatory Filings to Artworks or Project Management, Product Development Projects, Third Party Audits etc.
Managed Employee Onboarding & Exit, Expenses reimbursement, Accounting, Payrolls, Tax & Compliance
Full Office Infrastructure with IT & Administrative support (payments, work visas, travel bookings)
INDIA | STRATEGIC JV or ACQUISITION
India has a large number of manufacturing companies and choosing the right partner that provides maximum value and strategic fit is very crucial. Many global companies have set-up their base in India for supplies to their global markets. With first hand deep domain experience we help you get maximum advantage from India by connecting with promising JV/Acquisition targets / partners that possess desired complementary skillsets and facilitate strategic growth.
Our collective 50+ years industry-insider experience and network has helped us accumulate rare insights for spotting ‘HIDDEN-RARE-GEMS’ (highly competent but less known publicly) for Joint Venture or Acquisition imparting competitive edge to your business.
We help you undertake Technical and Commercial due diligence of potential target companies for evaluation of their complementary skillsets and value unlocking.
We undertake entire activity set right from identification to evaluation until completion of deals to uncover real value.
Establishing and Managing Indian Facility
- Identifying the right partner for JV or asset for Acquisition OR
- Complete feasibility study for new Greenfield Manufacturing / R&D Facility
- Undertaking Technical Due Diligence
- Location analysis and site selection
- Incorporation of local entity
- Regulatory approvals from Central and State government bodies
- Complete Turnkey Project management
- Executive search for key positions
India | Unlocking Huge Market
India is amongst world's fastest growing large economies with a huge population nearly twice that of all European countries combined. The domestic pharmaceutical market estimated at US$ 42 billion in 2021 is expected to grow 3x in the next decade. India's medical devices market stood at US$ 10.36 billion in FY20 growing at a CAGR of 37% and expected to reach US$ 50 billion by 2025.
A Huge Market capable of Transforming Business
India is a huge market that can rapidly transform the fortunes of any company. Understanding its potential, a large number of companies from across the globe are operating in India since several decades.
The market is characterised by huge volumes but is highly price sensitive, highly fragmented and operates in stark contrasts in many ways as compared to Western organized markets. Customer accessibility is the key driver and heavily hinges on the right choice of partnerships and entry plan.
We help connect with the most potential right mindset emerging companies that are flexible, poised for rapid transformation, have strong management team and established sales force that enjoys strong rapport with the target customers.
Partnerships for India Market Entry / Access
- Market Research & India market entry strategy
- Identifying and selecting the right partner for:
- Out-Licensing of Products
- Manufacturer / Co-Development / Co-Marketing Partner
- Help obtain necessary license and permits depending on the chosen model of entry.
- Executive search for top positions
GLOBAL QUALITY SYSTEMS
With over 30 years of robust track record of working closely with the world’s top-notch regulatory agencies in obtaining and maintaining global GXP compliance, we impart expert guidance in Assessment, Compliance & Global Accreditation of FDF, API Manufacturing & Clinical facilities, opening-up new frontiers for business growth.
Taking Quality to the Next Global Level
With our deeply engrained QbD knowledge base, we impart expert guidance for GMP/GLP/GCP/GDP compliance.
- Extensively worked on hands-on basis, right from greenfield facility creation to product development to Tech Transfer to regulatory dossier compilation, running regulatory approval procedures till grant of MA, and full scale regular Commercial Manufacturing and Supply.
- Highly experienced in a wide range of Finished Dosage Forms (Oral Solids/Liquids to small & large volume Injectables, Lyophilised products, Pre-filled syringes, Biologicals & Vaccines, Oncology, Hormones, Insulins, Penicillins, Cephalosporins), APIs (highly potent, Hormones, Insulins, Penicillins, Cephalosporins), Herbal and Nutraceuticals, Medicals Devices, Diagnostics & Disposables.
Our services include the following (both within India & Overseas):
1. Establishing NEW GREENFIELD MANUFACTURING FACILITY
2. RENOVATIONS of existing facilities to facilitate Global GMP APPROVALS
- Full-scale GAP Analysis for Quality Management System (QMS) improvement
- Implement Quality Risk Management and Validation Programmes
- Perform GMP Pre-audit of Manufacturing facilities, R&D Labs and BE Centre
- Help improve Document Management System (DMS)
- Help improve QC Laboratories functioning
- Validation of Utilities (HVAC, Water, Nitrogen and Compressed Air Systems)
- Help improve Equipment Qualification and Verification procedures
- Validation of Microbiological Methods
- Help implement Software Systems in QC Lab, QA, R&D and other operations
- Existing Software Validations (SAP, LIMS, TrackWise)
4. Perform THIRD PARTY VENDOR FACILITY AUDITS
5. Arranging European Qualified Person (QP) Audits
6. Participate in International (Regulatory) AUDITS
7.Assist in preparing AUDIT COMPLIANCE RESPONSES (FD 483, FDA Warning Letters)
8. EMPLOYEE TRAINING for knowledge improvement & sharpening skills
9. Help IMPROVE PRODUCTIVITY and provide suggestions to reduce Cost
- We undertake RENOVATION / TRANSFORMATION of existing manufacturing facilities to make them compliant as per desired Regulatory authority's norms.
- Arranging for European Qualified Person / QP Audit
- We facilitate INTERNATIONAL GMP APPROVALS of Indian or Overseas Formulations (Oral and Injectables) manufacturing facilities:
- US-FDA / EU-GMP / UK-MHRA / AU-TGA
- ZA-SAHPRA / BR-ANVISA / GCC
- PIC/s countries
We undertake for existing or potential Vendor / Supplier, Independent Third Party Audits:
- GEOGRAPHIES: India, Asian Countries & Japan
- PRODUCT TYPES: Finished Dosages or API
- AUDIT SCOPE could include:
- Manufacturing Site
- Clinical Facility
- Registration Dossier
We also arrange for European Qualified Person / QP Audit
We undertake complete end-to-end solutions (right from Concept to Commissioning) for creation of NEW GREENFIELD MANUFACTURING FACILITY:
- For Formulations or APIs
- In India or Overseas
Our Technical Team: We have a highly experienced 10 member technical team with hands-on experience and expertise in areas of QC/QA, Engineering, Production, Project management and Regulatory affairs to supervise and execute such projects.
Post audit of your facility, we provide assistance in preparing International AUDIT COMPLIANCE RESPONSES (FD 483, FDA Warning Letters).
- We impart EMPLOYEE TRAINING to your facility staff for knowledge up-gradation on GMP and regulatory guidance documents
- Help IMPROVE PRODUCTIVITY and provide suggestions to Reduce Energy Cost and Wastage
- We provide practical suggestions related to PRODUCT DEVELOPMENT and TECHNOLOGY TRANSFER
GLOBAL REGULATORY AFFAIRS
Over 30 years, we have undertaken global submissions and obtained more than 3600 Marketing Authorizations (MA) / Registrations in various countries from the most regulated ones to emerging countries. We are well versed with different class of products and multiple types of regulatory documentation submissions IND, ANDA, CTD, ACTD, DMF, SMF etc. and running various regulatory procedures.
Proactive Regulatory Affairs to support Business Growth
We help strengthen and sharpen regulatory skills that opens faster pathways to support International Business Growth.
Our services include the following:
- Documentation / Dossier Preparation, Review and Advisory for RA Compliance
- Preparation of DMFs (CTD), IND, ANDAs (CTD, ACTD ) for US and other Regulated Markets
- Review of Dossiers for their correctness and completeness
- Product Registration Dossiers for ROW Market
- Prepare query responses on submitted dossier
- Obtaining MA using the most suitable regulatory pathway
- Dossier Audit of Vendor for Completion & Compliance
- Pre-qualification program for WHO Geneva & other International Procurement Agencies
- Enter New Countries
- Build Global Alliance Network
- Expand Distribution Channel
- Out-License Products
- In-License Products
- Get CMO / CDMO Projects
- Get Global GMP Approvals
- Create Global Quality Systems
- Find API / FDF Suppliers
- Third Party Vendor Quality Audits
- Create Right Dossiers
- Answer Regulatory Queries
- Get Product Approvals / MA
- Launch New Products
- You Succeed