Discover
our wide range
of services


Specialized Services

Impurities standards

Impurities in pharmaceuticals are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during formulation, or upon aging of both API and formulated APIs to medicines. The presence of these unwanted chemicals even in small amounts may influence the efficacy and safety of the pharmaceutical products.

■ Pharmacopeia (USP/BP/EP/IP)
■ Non-pharmacopoeia/ In-house/ Customize (as per customer requirement)

Nitrosamine related compounds/ Impurities

Nitrosamine impurities are probable human carcinogens, their presence in medicines, even at trace level poses high safety risks to patients. We offer all kind of Nitrosamine impurities such as NDMA/ NDEA/ NDIPA/ NMPA/ NIPEA/ NMBA also API based nitroso amine.

Pharmacopeial Reference standards (WRS/CRS)

Pharmacopeial Reference Standards are a subset of Pharmaceutical Reference Standards. They are established for the intended uses described in pharmacopeial texts (both monographs and general provisions). We provide all kind of Reference standards (USP/BP/EP/IP)

Technology transfer of New & Generic APIs

We offer technology transfer & manufacturing trouble shooting for APIs and intermediates projects. Till we have done 26 products tech transfer successfully in India and overseas
• GI evaluation and reports
• Cost reduction at commercial scale
• CRAMS (Custom Synthesis) Development

Regulatory Affairs Support

We provide all kind of consulting services in Regulatory affairs for national and international markets: • Preparation of Regulatory strategy for dossier submissions • Dossier compilation for US, Canada, Europe, Australia, New Zealand and Emerging markets (Type: eCTD, CTD, ACTD or country specific)
• Dossier conversion to CTD/ACTD format.
• Regulatory gap assessment and mitigation
• Life cycle management a)Post approval changes (including site change) b) Re-registration/Annual updates c)Change Control Management d) Labeling updates e)Regulatory risk assessment f) Post approval regulatory commitment

GXP and GMP Consultancy

 We provide pharmaceutical GXP and GMP consultancy and auditing services. For this we only use leading industry specialists. Specialists who not only have a great deal of experience but also have practical skills and ability to get issues sorted. Our idea is that our consultants should be able to work with you and help you, rather than create even more work for you! We can help with the following areas of the pharmaceutical industry.

Auditing service

We perform supplier audits as well as internal audits against most recognized pharmaceutical standards. We use specialist sector-specific auditors as needed, including experienced IT/ Computer System auditors.

Inspection preparation

We help get sites ready for Regulatory and Corporate inspections, including working with groups to get their own areas ready. We can also assist behind the scenes during the inspection itself.

Global Sourcing support

We offers global sourcing support to our customers, which includes but not limited to…..
■ Speciality chemicals
■ Advanced Intermediates and KSM
■ Active pharmaceuticals ingredients (APIs)
■ Excipients
■ Reference list drug (RLD)/ Reference standard (RS)

Global Vendor (supplier) qualification and audits

We adopt a customer's assessment criteria and schemes, or alternatively can offer assistance to define the whole system of supplier qualification and the arrangement of specific tools. We have Lead Auditors strategically placed around the globe. They are members of a highly qualified team with extensive knowledge and know how in conducting audits/qualification of vendors.
Strong experience in dealing with Chinese Clients.
● Other technical service requirement to be answered by expert team.