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 opens pathways to reach out to new geographical terrains in Finished Formulations, API, Medical Devices, Clinical services and Pharma-Software domains.

Growth Enablers

What We Do

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

Credentials

Experience & Edge

  • Three decades of building a profitable global business portfolio in Europe, Canada, Australia, New Zealand, Asia Pacific, MENA and India regions

  • Obtained a multitude of GXP approvals, concluded over 135 agreements with a global clientele, more than 3600 product approvals commercialized over 45 countries

  • Robust hands-on experience right from greenfield facility creation, product development, Tech Transfer, dossier compilation, running regulatory procedures till grant of MA and full scale regular Commercial Manufacturing and Supply

  • Deeply ingrained QbD knowledge with a proven track record of obtaining and maintaining global GXP & regulatory compliance across marketing, sourcing, SCM, manufacturing, R&D, IP including cultural impact on business deliverables

  • Experienced in a wide range of dosage forms and therapeutic categories (from oral solids / liquids¬† to small and large volume Injectables, lyophilised products, Pre-filled syringes, biologicals and vaccines, oncology, hormones, insulins, penams, penicillins, cephalosporins) APIs, (highly potent, hormones, insulins, beta-lactam, fermentation-based), herbal / natural products, nutraceuticals and medicals devices

Core Benefits

Distinct Advantage

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

  • Niche knowledge of ‘treasured assets’ with a mindset for unlocking value from the right-fit partnerships, products and services

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

  • Transparent collaborative partnerships built on the highest levels of trust, integrity and business sustainability

  • Bringing the right team with proven methodology to challenge traditional thinking and driving transformation for unlocking market synergies

  • Creating profits from Indian resources with reduced risks, shortened turnaround times and spotting the most promising opportunities

  • 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-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