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We are knowledge led international business development experts, focussed on driving growth through synergistic international alliances and providing one-stop outsourcing solutions for products and services from Indian subcontinent.

 

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-Software domains.

 

We provide expertise, key insights and specialised knowledge for harnessing promising opportunities for marketing innovative products within India or internationally and professionally manage entire outsourcing value chain of products and services from India and Asia.

WHAT WE DO

What we do

We drive knowledge led 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 | Diagnostics | 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

VALUE PROPOSITIONS

Service Offerings

International Business Development

We create synergistic growth alliances with the right international partners using our key market insights from our extensive network and experience. 

Chart out sustainable Global growth from:

Venturing in the most potential -
Geographical Expansion with most promising Product Portfolio Expansion from inhouse or outsourced (in-licensed).

Profiting from India

We help you get maximum advantage from India by finding promising JV/M&A targets, outsourcing products & services, OR entering huge Indian market.

Outsourcing, Market Entry, Strategic Alliance

Establish "Virtual Indian Office" means local eyes & ears to constantly spot opportunities, better supplier relationships & streamlined operations.

Open doors of huge Indian market for your products with right-fit alliances.

Strategic JV / M&A for competitive advantage.

GMP / Quality Systems Compliance

Having spent 30+ years with the world's most stringent regulators, we undertake THIRD PARTY AUDITS & help build compliant Quality Systems.

Assesment, Compliance & Accreditation

We undertake THIRD PARTY AUDITS  for comprehensive assessment of facilities, help ensure compliance and obtaining accreditations like US-FDA / EU-EMA / UK-MHRA / TGA-AU / WHO-Geneva/ PIC/S / SAHPRA-ZA / ANVISA / GCC / CE, ISO and OHSAS Conformity Certifications.

01.

Global Business Development

We provide insights and create synergies with the right international partners for sustainable growth from :

Geographical Expansion

Product Portfolio Expansion

02.

India | Market Entry & Outsourcing

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03.

Global Quality & Regulatory

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04.

Digital & Software

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What We Do

We drive knowledge led international business growth in unexplored geographies via turnkey outsourcing of products and services, deploying a mix of the most appropriate:
Business Models
Licensing | Marketing | Distribution | Technology Transfer
Geographies
India | Europe | Canada | Australasia | SE Asia | MENA | GCC
Segments
Formulations | APIs | Medical Devices | Nutraceutical | Diagnostics | Clinical | Software
Niche Products
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

Services

Global Business Development

We provide insights and create synergies with the right international partners for sustainable growth from
Geographical Expansion
Product Portfolio Expansion

GMP / Quality Systems | Accreditation & Compliance

  • Help create new green field manufacturing facilities anywhere in India and abroad (from Concept to Commissioning)
  • Renovations of existing manufacturing facilities to make them Global Regulatory Compliant (US FDA, EU/EMA, MHRA, TGA, PIC/S, GCC)
  • Facilitate Indian and overseas formulations (oral and injectables) manufacturing facilities with attaining EU GMP approvals
  • Perform full-scale GAP Analysis of end-to-end Quality Management System
  • Help improve Quality Management System
  • 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
  • Help improve functioning of QC Laboratories
  • Perform Vendor Audits both in India and abroad
  • Validation activities (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, Track wise)
  • Help improve productivity and provide suggestions to reduce energy cost and reduce wastage
  • Product development and Technology Transfer
  • Employee Training for regulatory knowledge up-gradation on GMP and regulatory guidance documents
  • Participate in International Regulatory Audits
  • Assist in preparing International Audit compliance responses (FD 483, FDA Warning Letters)

Global Regulatory Affairs & Approvals

  • Help prepare DMFs (CTD), IND, ANDAs (CTD, ACTD) for US and other regulated markets
  • Review of dossiers for correctness and completeness
  • Help prepare Product Registration Dossiers in ROW Market
  • Help clients prepare query responses on submitted dossiers
  • Help participate in WHO pre-qualification programme, Geneva

Market Entry in India

We provide insights and create synergies with the right international partners for sustainable growth from

Global Outsourcing from India / Asia

We provide insights and create synergies with the right international partners for sustainable growth from

Digital and Software

We provide insights and create synergies with the right international partners for sustainable growth from

Contact

Address
Devdeep Tower, Satya Marg, Judges Bungalows
Ahmedabad, Gujarat 380015, India
+91 94266 49896

Hours
Monday–Friday: 9:00AM–6:00PM
Saturday : 10:00AM–4:00PM

Digital
Email: bizdiv@synergene.in
Mobile: +91 94266 49896 (WhatsApp & Telegram)
LinkedIn: www.linkedin.com/in/mbadonia

Contact

Get in touch to explore New Growth Horizons...

REACH US

Office
Devdeep Tower, Satya Marg, Judges Bungalows, Bodakdev, Ahmedabad Gujarat 380015 India

Phone
+91 7935911701

Email
bizdev@synergene.in