Value Propositions

Offerings

Enhancing Business Value

We catalyse International Business Growth by: 

  • Expanding International Business Network
  • Enhancing Global Quality & Regulatory competence 
  • Multiplying profits from Indian Outsourcing & Market Access.

Enhancing Business Value

We catalyse International Business Growth by: 

  • Expanding International Business Network
  • Enhancing Global Quality & Regulatory competence 
  • Multiplying profits from Indian Outsourcing & Market Access.

Services Portfolio

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

We catalyse international business growth deploying a mix of the most appropriate:

Business Models

Licensing (In & Out) | Marketing | Distribution | Technology Transfer

Geographies

India | Europe | Canada | Australasia | SE Asia | MENA | GCC | LatAm

Segments

Formulations | APIs | Medical Devices | Nutraceutical | Herbal | Clinical | Software

Product Lines

Oncology | Hormones | Peptides | MABs | NIBs | Respiratory | Ophthalmics

Global Quality and Regulatory Strategy

US FDA | EMEA | MHRA | TGA | PICS | ANVISA | WHO Geneva | GCC | CE | ISO | OHSAS

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.

End-objectives:

  • 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

Activities:

  • 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

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.

DISCOVER

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.

EVALUATE

We help you undertake Technical and Commercial due diligence of potential target companies for evaluation of their complementary skillsets and value unlocking.

ACCESS

We undertake entire activity set right from identification to evaluation until completion of deals to uncover real value.

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
    • JVs/Acquisitions
    • Manufacturer / Co-Development  / Co-Marketing Partner
    • Importer-distributors
  • 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

 
Offering services in the following areas:
  1. We undertake RENOVATION / TRANSFORMATION of existing manufacturing facilities to make them compliant as per desired Regulatory authority’s norms.
  2. Arranging for European Qualified Person / QP Audit
  3. We facilitate INTERNATIONAL GMP APPROVALS of Indian or Overseas Formulations (Oral and Injectables) manufacturing facilities:
  • US-FDA / EU-GMP / UK-MHRA / AU-TGA
  • WHO-Geneva
  • ZA-SAHPRA / BR-ANVISA / GCC
  • PIC/s countries

We undertake for existing or potential Vendor / Supplier, Independent Third Party Audits:

  1. GEOGRAPHIES: India, Asian Countries & Japan 
  2. PRODUCT TYPES: Finished Dosages or API
  3. 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

Helping
  • Enter New Countries
  • Build Global Alliance Network
  • Expand Distribution Channel
  • Out & In License Products
  • Access Niche, Orphan, Rare Products rights
  • Get CMO / CDMO / Tech Transfer Projects
  • Get GMP Approvals from Global Authorities
  • Create Global Quality Systems
  • Find API / FDF Suppliers
  • Third Party Vendor Quality Audits
  • Trigger EU GMP and EUQP / QPPV Audits
  • Respond Regulatory Queries
  • Get Product Registrations / MAs
  • You Succeed
for International Growth

Learn How We Catalyse your Growth ...