Team Synergene represents a comprehensive knowledge pool of globally experienced techno-commercial experts with a proven track record spanning > 25 years in International Marketing and Business Development, Global Quality Compliance and International Regulatory Affairs that help open pathways to swiftly reach out to new geographical terrains in Finished Formulations, API, Medical and Dental Devices and Clinical services domains.

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
Domain Experts

The Team

Manish Badonia

Founder & Managing Director

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

Dr. Arvind K Mishra

Co-founder & Technical Director

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

Credentials

Experience & Edge

  • Three decades of evolving synergies and building profitable global businesses in Europe, Canada, US, Australia, New Zealand, Asia Pacific, MENA, LatAm and India

  • Concluded over 180 commercial agreements with global clientele, obtained a multitude of GXP approvals and more than 4500 product approvals commercialized over 45 countries

  • Robust hands-on experience of greenfield facility creation, product development, Tech Transfer, dossier submission, grant of MA, regular Commercial Supply, QP, PV procedures

  • Deeply ingrained QbD knowledge with a proven track record of continuous global GXP / Regulatory compliances, sourcing, SCM, manufacturing, R&D, IP & cultural impact on busines

  • Experienced across a wide spectrum of life science domain products and services:

    • Finished dosage forms (oral solids / liquids, small / large volume Injectables, lyophilised products, Pre-filled syringes, biologicals, vaccines, oncology, hormones, insulins, penams, penicillins, cephalosporins)

    • APIs (highly potent, hormones, insulins, beta-lactam, fermentation-based)

    • Herbal / natural products, nutraceuticals, dental and medicals devices

Core Benefits

Distinct Advantage

  • Access to extensive network of key decision makers, corporate insights and deep industry knowhow

  • Knowledge of Niche / treasured assets & opportunities’ with a mindset for unlocking value from the right-fit partnerships, products and services

  • Creating profits partnering with India’s most treasured life science resources and promising opportunities, reducing risks and shortening turnaround times

  • Hands-on experience of mobilizing the most apt resources and solutions with robust execution to create faster pathways and better business outcomes

  • Building transparent collaborative partnerships with highest levels of trust, integrity and business sustainability

  • Having access to knowledgeable teams with proven methodology to challenge traditional thinking and driving transformation for unlocking market synergies

  • Ground-level-experts-led engagements to sharpen team skills on regulatory, commercial and business aspects
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