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Knowledge & Experience

Who We Are

Team Synergene represents a comprehensive knowledge pool of globally experienced techno-commercial experts with proven track record in International Marketing and Business Development, Global Quality Compliance and International Regulatory Affairs that opens pathways to reach out to new geographical terrains in Finished Formulations, API, Medical Devices, Clinical services and Pharma-focussed-Software domains.

Team Synergene represents a comprehensive knowledge pool of globally experienced techno-commercial experts with proven track record in International Marketing and Business Development, Global Quality Compliance and International Regulatory Affairs that opens pathways to reach out to new geographical terrains in Finished Formulations, API, Medical Devices, Clinical services and Pharma-focussed-Software domains.

Value Propositions

Offerings

Enhancing Business Value

We catalyse business growth by:

Expanding international business network
Enhancing Quality & Regulatory competence
Multiplying profits from Indian Outsourcing & Market Access.

Helping

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

for International Growth

Services Portfolio

Global Business Development Read More Outsourcing Edge from India Read More Unlocking Huge Indian Market Read More Global Quality Systems Read More Global Regulatory Affairs Read More Strategic JV & Acquision Read More

All-in-One Solution

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Nonstop Updates

We strive to innovate when it comes to functionality. Our mission is to be the best, come and join the ride.

Advanced Tools

Add more power to Elementor using our creative elements and make your projects look prettier than ever before.

24/7 Dedicated Support

Each and every one of our customers receives personalised assistance from our dedicated support team.

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 to partners to products.

Entering New Countries
Product Portfolio Expansion

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 EU, ANZ or Canada
HIGH GROWTH EMERGING Territories in SE Asia, Middle East, Africa, Latin America
INDIA - a huge high potential market

For incremental revenues, we help you get access to New Differentiated Products (in-licensing or distribution rights) in your portfolio:

Special Rx Products [Oncology, Hormones, Respiratory MDI/DPI, Liposomal, Niche Injectables, MABs, NIBs, Suppositories], Orphan Drugs
Differentiated OTC or Food Supplements
Differentiated Medical Device

Outsourcing with India Edge

We help you derive maximum advantage from India's global edge and prominence in Pharmaceuticals, Medical Devices and Healthcare by facilitating strategic growth partnerships.

Efficiently Build & Manage Outsourcing Alliances

We facilitate efficient sourcing of low-cost high-quality Products & Services. We deeply understand India, its corporate culture and have accumulated knowledge of a lot of ‘hidden gem’ highly competent companies that are below the line of sight and routine radars. With our deep domain knowledge, trusted network, internal insights and ground knowhow of local nuances, 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 experience allows us to successfully bridge the gap tweaking 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.

Finished Dosages [FDF]
APIs & Intermediates
Supply Chain & Logistics
Third Party Quality Audits
Strategic JV / Acquisitions

Contract Manufacturing [CMO] / Site Transfers – FDF and API change
Licensing-In [Products & Technologies]
- Special Rx Products [Oncology, Hormones, Respiratory MDI/DPI, Liposomal, Niche Injectables, MABs, NIBs, Suppositories], Orphan Drugs
- Differentiated OTC, OTX or Food Supplements
- Differentiated Medical Device
Contract R&D [CDMO] for Development / Stability Studies / Analytical Development
Clinical Research [CRO] & Bioequivalance Studies
Regulatory Support [Dossiers / Expert Reports / Pharmacovigilance]
End-to-End Project Tracking: From R&D / Development & Registration until Launch

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

DISCOVER:

Our collective 50+ years industry-insider experience and network has helped us accumulate rare insights for spotting 'HIDDEN-RARE-GEMS' (highly competent but not so well known publicly) for Joint Venture or Acquisition imparting competitive edge to your business.

EVALUATE:

We help undertake Technical and Commercial due diligence of such right-fit complementary skillset companies.

ACCESS:

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

GLOBAL QUALITY SYSTEMS

With over 30 years of working closely with the world’s top regulatory agencies, we help in Assessment, Compliance & Global Accreditation of FDF, API Manufacturing & Clinical facilities.

Taking Global Quality Compliance to the Next Level

We help you strengthen knowledge base and sharpen GMP & Regulatory quotient opening-up new possibilities.

Robust track record and deeply engrained QbD knowledge base spanning over 3 decades of obtaining and maintaining global regulatory and GXP compliance with multitude of facility and product approvals from the world’s most stringent regulators.
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:

1. NEW GREENFIELD MANUFACTURING FACILITY CREATION (from Concept to Commissioning) – in India or Overseas for Formulations or APIs
2. RENOVATIONS of existing manufacturing facilities to make them Global Regulatory Compliant
3. Facilitate APPROVALS of Indian or Overseas Formulations (Oral and Injectables) manufacturing facilities (US-FDA / EU-EMA / UK-MHRA / AU-TGA / PIC/s / ZA-SAHPRA / BR-ANVISA / GCC / WHO Geneva), CE / ISO / OHSAS Conformity Certifications
 Perform full-scale GAP Analysis of end-to-end Quality Management System
 Help improve Quality Management System (QMS)
 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 System, Water System, Nitrogen System and Compressed Air System)
 Help improve Equipment Qualification and Verification procedures
 Validation of Microbiological Methods
 Help implement Software Systems in QC lab, QA and other operations
 Existing Software Validations (SAP, LIMS, TrackWise)
4. Perform THIRD PARTY VENDOR FACILITY AUDITS both in India and overseas
5. EMPLOYEE TRAINING for regulatory knowledge up-gradation on GMP and regulatory guidance documents
6. Participate in International REGULATORY AUDITS
7. Assist in preparing International AUDIT COMPLIANCE RESPONSES (FD 483, FDA Warning Letters)
8. PRODUCT DEVELOPMENT and Technology Transfer
9. Help IMPROVE PRODUCTIVITY and provide suggestions to Reduce Energy Cost and Wastage

New Manufacturing Facility
Facility Renovation & Approval
Third Party Quality Audits
Training & Improvement
Audit Compliance Responses

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 8-10 members technical team with hands-on experience and expertise in areas of QC/QA, Engineering, Production, Project management and Regulatory affairs.

We undertake RENOVATION / TRANSFORMATION of existing manufacturing facilities to make them compliant as per requisite Global Regulatory norms.

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

As a a natural outcome of our knowledge of Quality Systems, we undertake for your existing or potential Vendor / Supplier, Independent Third Party Audits:

COUNTRIES: India, Asian Countries & Japan
PRODUCT TYPES: Finished Dosages or API
AUDIT SCOPE could include:

Manufacturing Site
Clinical Facility
Registration Dossier

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 suggestions related to PRODUCT DEVELOPMENT and Technology Transfer

Post audit of your facility, we provide assistance in preparing International AUDIT COMPLIANCE RESPONSES (FD 483, FDA Warning Letters).

GLOBAL REGULATORY AFFAIRS

Over 30 years, we have undertaken global submissions and received more than 4500 Marketing Authorizations (MA) / Registrations in various countries from the most regulated to emerging countries. We are well versed with all types of regulatory submissions IND, ANDA, CTD, ACTD, DMF, SMF etc for various classes of products.

Proactive Regulatory Affairs supporting Business Growth

We help strengthening and sharpening 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
Participation in Pre-qualification program for WHO Geneva & other International Procurement Agencies

We are knowledge led business development experts driving international business growth through synergistic global alliances within India and internationally.

Through our expertise, key insights and specialised knowledge, we help harness promising opportunities and professionally manage entire outsourcing of products and services from India and Asia.

Using our 30+ years experience working closely with the world’s most stringent regulators, we help build compliant Quality Systems and Regulatory expertise.

Value Propositions

Service Offerings

Global Business Development

We pave synergistic growth through entry in new international markets with the right-fit partners from: Geographical Expansion Product Portfolio Expansion

Learn more

Global Quality Systems

With over 30 years of experience with the world’s top regulators, we help in Assessment, Compliance & Global Accreditation of Facilities.

Learn more

Profiting from India

Derive maximum advantage from India from Strategic Partnerships for: Outsourcing Products & Services, JV or M&A, Entering huge Indian market

Learn more

Global Regulatory Affairs

Complete Dossier services until grant of MA / Registration, Third Party Dossier Audits, Pre-qualification programs of International Procurement Agencies.

Learn more

Global Business Development

We pave synergistic growth through entry in new international markets with the right-fit partners from: Geographical Expansion Product Portfolio Expansion

Learn more

Global Quality Systems

With over 30 years of experience with the world’s top regulators, we help in Assessment, Compliance & Global Accreditation of Facilities.

Learn more

Profiting from India

Derive maximum advantage from India from Strategic Partnerships for: Outsourcing Products & Services, JV or M&A, Entering huge Indian market

Learn more

Global Regulatory Affairs

Complete Dossier services until grant of MA / Registration, Third Party Dossier Audits, Pre-qualification programs of International Procurement Agencies.

Learn more

Domain Experts

Meet The Team

+91 94266 49896

Manish Badonia

Founder & Managing Director

Manish brings in over 25 years of techno-commercial Global Business Development experience.

+91 90990 98264

Dr. A K Mishra

Co-Founder & Technical Director

Dr. Mishra is an industry veteran with >3 decades Global experience in Technical, Quality & Regulatory.

Manish Badonia

Founder & Managing Director

Manish is an experienced techno-commercial business development professional bringing in 25+ years experience garnered with top companies. He has extensively travelled > 30 countries sharpening his core expertise in spotting & transforming opportunities into profitable global businesses, deploying right-fit partners, business models, products & geographies.

Dr. Arvind Mishra

Co-Founder & Technical Director

Dr. Mishra is an industry veteran with over three decades of robust experience in global quality, regulatory and strategy. As a highly accomplished leader, he drives Technical, GMP & Regulatory Projects in Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs, R&D & Clinical Research in APIs, FDFs, Biologicals and Medical Devices.

Manish Badonia

Managing Director

Manish is an experienced techno-commercial business development professional bringing in 25+ years experience garnered from travel in 40+ countries. His core expertise is spotting & transforming opportunities into highly profitable global businesses, deploying the right-fit mix of partners, business models, products and geographies.

Manish Badonia

Managing Director

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View All Members

Manish Badonia

Managing Director

Manish Badonia

Managing Director

About Us

We are knowledge led business development experts, focussed on driving international business growth through synergistic global alliances within India and internationally.

Through our expertise, key insights and specialised knowledge, we help harness promising opportunities and professionally manage entire outsourcing of products and services from India and Asia.

Using our 30+ years experience working closely with the world’s most stringent regulators, we help build compliant Quality Systems and Regulatory expertise.

Value Propositions

Service Offerings

About Us

We are knowledge led business development experts, focussed on driving international business growth through synergistic global alliances within India and internationally.

Through our expertise, key insights and specialised knowledge, we help harness promising opportunities and professionally manage entire outsourcing of products and services from India and Asia.

Using our 30+ years experience working closely with the world’s most stringent regulators, we help build compliant Quality Systems and Regulatory expertise.

Transparency

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Experience

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Integrity

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Global

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Strategy and Planning

We bring the right people together to challenge established thinking and drive transform in 2020

Strategy and Planning

We bring the right people together to challenge established thinking and drive transform in 2020

Strategy and Planning

We bring the right people together to challenge established thinking and drive transform in 2020

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Inherent

Transparency

Time has changed

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Growth Enablers

Integrity

Growth Enablers

Quality

Value Propositions

Service Offerings

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Transparency

Reflecting our total commitment to trust and transparency, we directly connect business partners.

Integrity

Integrity is natural and our absolute business trait. We are committed to 'Talk your Thought, Walk your Talk'.

Quality

Quality is deeply ingrained in our mindset an omnipresent quintessential habit of our lives and work.

Unique Elements and widgets

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