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Product Portfolio Development
& Enhancement

Diversify your Product Portfolio involving market expansion strategies from Concept Building to Development, Regulatory Approvals and Commercialization. Adapt to ever-evolving standards for a sustained success.

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Global Regulatory Affairs
& Compliance

Understand the Regulatory Landscape to devise most favorable Regulatory Strategies. Be flexible and adaptable to changes in the Regulatory Environment.
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Integrated Packaging
Solutions

Elevate your Product Packaging to new heights. We assure Regulatory Compliance in Packaging Design, Artwork management and Supply of superior quality Packaging
Materials

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Explore with us

Generics
New Dosage Forms
New indications
INDs
Herbals Products
Nutritional Supplements
Veterinary Products
Topical Products

Our Main services

Product Development Partnerships
From conceptualization to market launch, we offer a full spectrum of services, ensuring seamless support across all stages of drug development. Our expertise lies in identifying challenges early on during the product development stage, potentially saving time and resources, and accelerating the overall development timeline. We help upgrade the existing product portfolio for market expansion and identifying partners for out-licensing/in-licensing.
Global Regulatory Submissions
We author and compile INDs, NDAs, ANDAs, MAAs, CTAs, DMFs, prepare eCTD, oversee the entire submission process and ensure compliance with regulatory requirements. The regulatory documentation are tailored to country specific requirements. We offer regulatory services for India, USA, UK, EU, Asia, EA-EU, CIS, Africa, Middle- east, Australasia, WHO-PQ.
Due Diligence
We perform a 360 degree due diligence on drug product dossiers with a multidisciplinary approach involving regulatory, scientific, legal, and financial expertise. The objective is to thoroughly assess the quality, completeness, and compliance of the dossier before making business decisions.
Life Cycle Management
We offer life cycle management services including entering new geographic markets and exploring novel formulations, new dosage forms, line extensions to maximize the product's market potential. Plan post approval studies strategically to unlock the additional value of your licensed products for a broader market. We manage post-market compliance activities, variations, renewals for our business partners.
Sourcing and Qualification
Reliable cost effective pharmaceutical sourcing and qualification of suppliers are essential for business continuity. Contact us for your procurement needs for APIs, excipients, primary and secondary packaging, reference standards and drug products. We help in establishing and maintaining quality agreements with suppliers with defined roles, responsibilities, and quality expectations.
Packaging Design, Development & Supply
We implement serialization technologies to enable track-and-trace capabilities, design and provide protective packaging materials, labels for high speed packing machines, anti-counterfeit measures, child-resistant packaging that are compliant with heath authorities regulations.

Global Regulatory Affairs

Assisting you in attaining world wide product registrations.

We serve as your gateway to effortless global market entry. Streamlining the route to product approval, we customize regulatory strategies for each country right from the initial stages of your product & development. Embark on the path to international success with assurance and expertise accompanying you every step of the way.

Providing you Extensive Regulatory Services encompassing Strategic Planning for Marketing Authorizations, Scientific Dossier Writing, Submission to Health Authorities, Deficiency Resolution, Product Life Cycle Management, serving as the Point of Contact for Regulatory Authorities, Assigning In-country Agents, Distributors and Importers.

UK
EAEU
WHO-PQ
ASEAN
AFRICA
MIDDLE-EAST
CIS
EUROPE
USA
AUSTRALIA

Integrated Packaging Solutions

Package Design & Artwork Development
Supplier Identification and Qualification
Manufacturer’s Audit
DMF Submissions
Implementation of Serialization Technologies
Tamper Evident Packaging
Packaging Material Supply

“Regulatory & Compliance Services for India”

We assist you in navigating through the Complex Regulatory Framework in India at Central and State Level

Drugs

Biologics

Medical Devices

Medical Devices

Drug
Drug
1. New & Subsequent Drug Approvals
2. Clinical Trial Approvals
3. BA/BE NOCs
4. Registrations for Import
5. Post Approval Changes
6. Test Licenses
7. Manufacturing License
Biologics
Biologics
1. RCGM Approvals
2. Clinical Trial Approvals
3. Registration for Import
4. Post Approval Changes
5. Test Licenses
Psychotropics & Precursors
Psychotropics & Precursors
1. Import Permits
2. Export Permits
3. Advisory on Record Keeping
Other Categories
Other Categories
1. Food
2. Cosmetics
3. Medical Devices
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