Pharmaceutical Regulatory Services

Compliance Made Simple

Navigating the Complex

World of Pharmaceutical Regulations

Unlocking Market Potential

with Regulatory Compliance

Welcome

Get Know About Us!

We are a pharmaceutical regulatory service provider, founded by industry veterans with a wealth of experience in the field. Our mission is to provide top-notch regulatory services to pharmaceutical companies, helping them navigate the complex landscape of pharmaceutical regulations.

Our founders, with their extensive experience and deep understanding of the pharmaceutical industry, have instilled a culture of excellence and a commitment to quality in our organization. We understand the challenges faced by pharmaceutical companies in complying with regulatory requirements and are here to offer our expertise and support.

Our services include regulatory consulting, submission of regulatory documents, liaison with regulatory authorities, and much more. We are committed to providing our clients with reliable, efficient, and cost-effective solutions to meet their regulatory needs.

We believe in building strong relationships with our clients, based on trust, transparency, and mutual respect. We work closely with our clients to understand their specific needs and provide customized solutions that align with their business objectives.


Thank you for visiting our website. We look forward to the opportunity to serve you.

Mission

Mission

Our mission is to provide comprehensive regulatory affairs consulting services to pharmaceutical companies worldwide. We aim to navigate the complexities of global pharmaceutical regulations, ensuring our clients’ products meet the highest standards of safety, efficacy, and quality. We strive to expedite the regulatory approval process, enabling our clients to bring their innovative and products to market as quickly as possible.

- Sira Pharma consultancy

Core Values

Integrity

Integrity

We uphold the highest ethical standards in all our work & maintaining transparency in our dealings with clients and regulatory authorities.


Excellence

Excellence

We strive for excellence in all we do, continually improving our skills and knowledge to provide our clients with the best possible service.


CustomerFocus

Customer Focus

We put our clients at the center of everything we do, striving to exceed their expectations and help them achieve their business objectives.


Professionalism

Professionalism

We conduct ourselves with professionalism at all times, demonstrating competence, reliability, and respect for our clients and colleagues.


Quality

Quality

We are committed to providing services of the highest quality, ensuring that all regulatory submissions are accurate, complete, and compliant with all relevant regulations and guidelines.


Confidentiality

Confidentiality

We understand the sensitive nature of the information we handle and are committed to maintaining strict confidentiality and data security protocols.

We look forward to partnering with you on your journey to regulatory approval and market success.


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Our Advantage

Expert Guidance: We provide strategic advice on regulatory submission and compliances.

Streamlined Processes: We handle every step from pre-approval to post-approval.

Risk Mitigation: Our in-depth knowledge helps you avoid potential fines and noncompliance.

Cost Savings: We devise strategies that expedite the registration, saving you time and money.

Customized Solutions: We tailor our services to meet your specific needs.

Faster Time to Market: Our efficient processes can help you bring your product to market quicker.

Our Industries

We assist clients with quality and regulatory needs in multiple life science industries.

Services


Our Services
We provide unique and professional services in Regulatory Affairs, Quality assurance, and clinical matters. Our technical proficiency, accessibility, and cost-effective rates are aspects you can rely on.

We assist our client in many areas, Including.

Regulatory Affairs

  • Strategy
  • Domestic & Foreign Submissions
  • Tech Filess
  • Registration & Licensing


    Compliance

    Compliance

  • Auditing – Internal & Supplier Audits
  • Query & Warning Letter Response
  • Mock Inspections
  • Audit Readiness


    Quality

    Quality Assurance

  • Development of QMS
  • Gap Analysis
  • CAPA | Complaint handling
  • Validation
  • Qualifications of equipments


    Reach out to us today to explore your requirements and see how our top-tier expertise can transform your business.

    Contact Us



    Regulatory Affairs
    The regulatory environment is constantly evolving.
    Our team of seasoned professionals guarantees adherence to these changes.
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    Regulatory Strategy
    We help clients develop a comprehensive regulatory strategy that aligns with their business objectives and ensures compliance with all relevant regulations.

    Regulatory Submission
    We assist clients in preparing and submitting regulatory documents to the appropriate regulatory authorities. This includes MAA, ANDA, DMF and renewals, etc

    Regulatory Compliance
    We help clients ensure their operations, processes, and products are compliant with all relevant regulations includes ICH, US CFR and etc.
    Post

    Post-Marketing Surveillance:
    We assist clients in monitoring the safety and effectiveness of their products after they have been launched on the market.

    Liaison with Authorities
    We act as a liaison between clients & regulatory authorities, facilitating communication and ensuring a smooth regulatory process.

    Labeling and Promotional Material:
    We prepare and review product labeling and promotional materials to ensure they are compliant with regulatory requirements

    Quality Assurance
    Our team is skilled in the development and enhancement of quality systems that adhere to ICH, 21 CFR, and other standards.
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    Quality System management
    We assist clients in the preparation of Policies Process and Procedures that comply with all current regulations.

    Audit Service
    “We perform a variety of audits, both onsite and remotely, which include supplier audits, internal audits, simulated FDA inspections, and process audits.

    Gap Analysis
    Our thorough Gap Assessments scrutinize processes and pinpoint areas that need enhancement.
    QA

    Other QA services

    FDA query and warning letter response

    CAPA preparation

    Complaint handling

    Validation service – Protocol preparation and Execution

    Qualification Service - Protocol preparation and Execution

    Implementation of 21 CFR part 11 and Computer System Validation

    Get in touch with us today to talk about your requirements and experience the impact our exceptional expertise can have on your business.

    Contact Us

    Our Clients

    Who make us proud

    Adwaa LanaAdwaa Lana
    UAE
    Bavarian NuturwegBavarian Nuturweg
    Germany
    New Path MedicalsNew Path Medicals
    KSA
    Amca PharmAmca Pharm
    Germany
    Wahi PharmaceuticalsWahi Pharmaceuticals
    USA
    Pharm Tech NaturaPharm Tech Natura
    Germany
    GehrlicherGehrlicher
    Germany
    Standl NaturaDr. Standl Natura
    Germany
    Fidelio HealthcareFidelio Healthcare
    Germany
    Nomou United Medical CompanyNomou United Medical Company
    KSA
    Marina NaturaMarina Natura
    Germany
    Jeyada LLCJeyada LLC
    Kuwait
    IrbitIrbit
    Russia
    HedenkampC. Hedenkamp & Co
    Germany

    Contact Us

    Let’s start exchanging

    India Operations

    Sira Pharma Consultancy
    C8/8510 Vasant kunj, New Delhi -110070

    E-Mail Us

    info@sirapharmaconsultancy.com

    Middle East Operations

    Eusano Middle East
    Ezzat Al Nuimat 8-Khalda-11821 Jordan

    Europe Operations

    PharmTech Natura GmbH
    Kurfürstendamm 234, 10719 Berlin, Germany

    Have Any Query? Please Contact Us

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